That's right. The FDA today approved Concerta, a stimulant, for use in treating ADHD/ADD in adults. Like Ritalin, it contains methylphenidate, so here we go giving adults speed to make them productive workers. If someone wants to take this drug due to genuine problems, fine. Get a complete cardiac work up first, OK?
I'm looking forward to the marketing campaign that will come from J&J, a division of which makes the drug.
I don't write about autism much on this site because it's a bit out of my wheelhouse and because making a statement in either direction on the vaccine connection/non-connection to the disorder invites a huge fight that is almost impossible to sort out. Anyway, there was an NIMH-sponsored meeting in Indianapolis yesterday to bring experts together to discuss a recently-publicized case where the government admits that a girl's autism was most likely related to being vaccinated. The apparent connection was driven by diseased mitochondria in the girl.
In advance of the meeting, the New York Times' excellent Gardiner Harris dug up records indicating a second apparent case, this time out involving a girl who took a FluMist vaccine earlier this year and a week later:
"'[B]ecame weak with multiple episodes of falling to ground' and 'difficulty walking,' according to a case report filed with federal health officials and obtained by The New York Times."The girl grew increasingly weak and feverish and 'became more limp, appears sleepy, acts as if drunk,' the report said. She was hospitalized and underwent surgery and was finally withdrawn from life support. She died on April 5, according to the report."
It wasn't clear if experts were going to discuss this case as well and I've seen no subsequent press coverage of the meeting so far. I pass all of this along for what it's worth to you.
My own view is that, since the Institute of Medicine declared that there was no scientific evidence of a vaccine-autism link in 2004, there has certainly been increasing noise around the disorder and the scientific consensus. And, it's enough to make me think that something very odd has gone on with all of these children that has little to do with what we think we already know. What it is, I don't know. Maybe no one does.
If you want to see how heated things can get, check this comment thread at Age of Autism where Harris is savaged for not being aggressive enough, even though he's just pushed some vital information out into the public sphere.
A fascinating op-ed ran in the Boston Globe last week and I'll quote from it a bit and you'll get what's going on here. The gist is that Pfizer sponsored a survey of Cape Cod residents and found that 43 percent showed symptoms of depression, not depression as it's clinically understood which would've hit perhaps 7 percent to 10 percent of Cape residents. Pfizer makes Zoloft.
"This study was conducted only on the Cape, and it used a survey created by pharma giant Pfizer, which has a financial interest in the number of anti-depressant prescriptions being written. And in a break from usual medical protocol, it was handed out in waiting rooms to people who, for the most part, had come to the doctor for reasons having nothing to do with getting help for depression or its symptoms."That was the case last fall when I went to my doctor for a persistent chest bug. Without explanation, the receptionist handed me a survey that asked whether in the past two weeks I had "been bothered" by a list of symptoms, including "feeling down," "trouble falling asleep, or sleeping too much," "feeling tired," "poor appetite or overeating," and "feeling bad about yourself."
"Setting aside that my cough and fever had brought on most of these symptoms, I was startled by the aggressiveness of the inquiry, as well as the nonchalance of its administration. Unlike more typical medical forms that ask about diseases you've had in the past, this one seemed to be looking for a condition that hadn't yet been diagnosed, for which the patient was not necessarily seeking treatment. And, unlike an effort to prevent a contagious disease from threatening the public health, this one targeted an affliction of a highly personal nature, not known to spread through physical contact, or even propinquity.
"Now, all of a sudden, the nurse taking my blood pressure and weight was reviewing my completed survey and wondering if I should talk to the doctor about it, along with my nagging cough."
The upshot is that doctors thought this was a good way to start a "conversation" with patients about depression. Pfizer is perhaps the only party to the exchange who stood to benefit.
The only conversation docs ought to have is within their own profession about how they are trying to link depression with absolutely everything and about how they are becoming a wee bit too intrusive into every aspect of their patients' lives and about how they are getting to be the equivalent of bait-and-switch salespeople: "Came in to discuss a cold? Well have I got the SSRI for you?"
It's because of episodes such as this one that I openly lie on those little screening forms doctors give you these days each time I visit a doc.
That's the term the Indianapolis Star used in an article this weekend to describe Eli Lilly's blockbuster anti-depressant and it's an apt one. Since being approved for depression in 2004, Lilly has gotten the drug approved by the FDA for generalized anxiety, maintenance treatment of depression (it's never been clear to me why the company needed a long-term indication for depression), diabetic nerve pain, fibromyalgia and stress urinary incontinence (Europe only). The company has also submitted it to the FDA for approval as a treatment for chronic knee and low back pain. I cannot think of a single psych med that has been repurposed so often, although Paxil does have seven indications but those are all for DSMable conditions not pain management.
As I noted recently, one Lilly-run study of the drug for knee pain generated an effect size of 14 percent over placebo. Pretty unimpressive. There have also been published studies questioning just how effective Cymbalta is at treating pain as well as other anti-depressants.
I've been leery of the anti-depressants for pain paradigm for some time now, principally because of the rotten side effects that Cymbalta and other anti-depressants are heir to. Others are leery of Cymbalta and Lilly for other reasons:
"'The question you have to ask is, are drug companies using all their scientists to look at new uses for drugs they already have, at the expense of developing new drugs?' said Dr. Lon Castle, senior director for medical and analytical affairs at Medco Health Solutions of New Jersey, one of the nation's largest drug distribution companies."
It's a fair question, but Lilly has certainly benefitted from the federal and states push to get pain patients away from opiates. As the paper notes in a cautionary way:
"Like all antidepressants, the drug has a black-box warning that it may increase the risk of suicide in people younger than 25. In 2004, a 19-year-old drug-testing volunteer, Traci Johnson, hanged herself in the Lilly Clinic in Indianapolis while participating in clinical trials for Cymbalta. The drug also carries a long list of possible side effects, from nausea and dry mouth to fatigue and constipation."'I think the question is, should one drug compound do so much?' said Shannon Brownlee, author of 'Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer.'
"'This is a drug that may have a really serious side effect called suicide,' Brownlee said. 'Don't we have other drugs available that are safer and just as effective for such things as the management of chronic knee and low back pain?'"
Indeed.
Sen. Charles Grassley (R-Iowa) is sure turning into a one-man wrecking crew for many psych researchers and will probably move onto other branches of medicine soon enough. He's already exposed massive conflicts and misreported payouts from pharma companies involving three Harvard child psychiatrists and one at the University of Cincinnati. Now, it's Stanford's turn with Grassley this week reporting that Alan Schatzberg, chair of Stanford's psychiatry department, has more than $6 million worth of stock in Corcept Therapeutics, a company trying to turn mifepristone into a depression treatment. That's not against the law, of course, and he reported the holdings in line with the university's regulations (he reported holding at least $100,000 in the stock), but you do have to wonder about just how disinterested his research and public pronoucements about depression treatment actually are.
You also have to wonder just how interested the psych field is in gaining the public's trust and in doing old-fashioned, conflict-free science--you know the kind that actually serves patients.
Schatzberg, as CL Psych points out, is a big hitter in the psych world. He's incoming president of the APA and has publicly touted Zyprexa, a drug with a very troubled history. You do have to wonder where Grassley is taking all of this--new regulations, a broader Congressional investigation or what?
Something clearly needs to be done. You'd think at a minimum that the APA would have some kind of rules governing these kinds of conflicts, especially for its new president, as Danny Carlat notes and that Stanford would feel uneasy about having an academic department chair so deeply in bed with a company trying to bring a drug to market.
"Arthur Caplan, chair of the Department of Medical Ethics at the University of Pennsylvania, agrees. 'The continuing number of problematic cases regarding investigator disclosures makes it clear that universities, academic health centers and professional societies must set clear conflict-of-interest standards for all to follow - or Congress is likely to do so,' he said."Dr. Bernard Carroll, former head of psychiatry at Duke University, said that Schatzberg and Stanford complied with the letter of the law - but not its spirit.
"'He disclosed ownership of more than $100,000 of stock. But, whoa - that is a real lowball. It is actually $6 million,' he said.
"'You can give a laundry list of what you're connected with - but buried in that, and unrecognized by the average reader, is really salient information about how close your association is with a company,' Carroll said."
BTW, Health Care Renewal and CL Psych were onto Shatzberg well before Grassley. But, then, maybe the Senator's staff are readers of mental health blogs.
A report released earlier this week by the Center for Public Integrity states that drug and device manufacturers spent $168 million on lobbying in 2007, an increase of 32 percent over 2006. Pharma companies are the biggest lobbyists on Capitol Hill. Obviously, pharma companies get a return on their investment or they wouldn't spend this kind of money--and when it comes to political candidates, the companies gave more to Dems than to Republicans in the most recent election cycle. I guess they are trying to influence all those new Dems in Congress.
With spending like this, it's a wonder patients get the ear of Congress at all. Or do we?
St. Jude Medical has begun a fresh trial of deep brain stimulation for the treatment of depression--and I'd have to assume that we're talking extremely severe depression in these cases, given that the device and technique are still experimental. I know a lot of readers have very strong views about mixing electricity and the brain--I share those views for the most part--but, as with ECT, I'm not opposed to people giving this sort of approach a go. It's their bodies, brains and lives after all, and there are people who get depression so severe that meds, psychotherapy and whatever other voodoo they try don't help.
It'll be interesting to see how the trial on two patients pans out. There was a really good article in the New York Times Sunday magazine two years ago on the procedure and the people using the treatment in Canada, if you are interested.
This has to be one of the oddest suicide stories I've ever encountered--a family of five in San Clemente, Calif. has apparently committed suicide en masse, two by gunshot, three by unclear means. But even the cops are saying it appears like a group suicide, although final determination depends on toxicology reports. Outside of the Heaven's Gate cult business in San Diego 11 years ago, this is one of the few examples I know of of group suicide.
It's also creepy, weird and sad.
I hate the idea of cutting off anyone's free speech, but I've really come around to the thinking that posting comments here is a privilege not a right. Yesterday I had to ban two people from commenting permanently and put another on a temporary ban. I don't want get into specifics except to say that one person attacked me personally--never a good idea--and another was someone banned previously who came back from a different IP address (nice try, dude) while the third is someone who has driven off a couple of regular readers and commenters in recent days, and I just won't tolerate grandstanders driving away people who maintain an appropriately civil tone.
That brings me to seven people I have banned in the almost three years this blog's been around. Compared to other sites, that is a very low number. I bumped into a neighbor of mine this evening who's been in the tech world for years and told him I was bummed about banning people. He joked that I should at least enjoy the power. I told him I didn't. In fact, it stresses me out. So stressed was I that I took the entire evening off. I'll catch up with posts later this morning.
In an odd way, I'm pleased that my work here and the comment threads generate such passion but there are limits. As a result, I will soon be updating this site's commenting policy with an eye towards maintaining open, mature debate and conversation. Stay tuned.
This will have to count as a setback for neuropsych researchers, who've been insisting for years that if they can find a central gene (or genes) tied up with a particular mental disorder, then they could predict response to drugs used to treat the disorder. New research is out today in Neuropsychopharmacology asserting that discovery of a gene polymorphism that seemed to predict the severity of ADHD symptoms has not lead to an ability to predict patient responses to Ritalin, Adderall and the other ADHD-treatin' stimulants. And that runs counter to what researchers had expected.
"'What we found is that the children who have two copies of the Val isoform had an even harder time orienting their goals than children who are homozygous for Met [that is, have two copies of the Met isoform] or even Val/Met,' [the researcher] said. Each person two copies of the COMT gene, one from each parent."Yet the researchers observed no correlation between the type of variant and response to methylphenidates; the drug reduced ADHD behavior in all individuals regardless of genotype.
"'We expected this polymorphism would also modulate response to medication, but it didn't,' said Joober. 'In other words, that means that whether you have the Val or Met allele, it will not change your level of response to medication with respect to task- or goal-oriented behavior.'"
Some researchers note that this is actually an opening door for more complex research into the neurology of ADHD and drug response.
I'll believe it when I see it.
A new article in the Psychiatric Times by an Italian and British researcher finds little support for the use of anti-depressants in treating the depressive side of bipolar disorder. The articles makes its argument very cautiously since its core assertion is running counter to received wisdom and practice in the clinical world, but it lines up with earlier evidence showing that anti-depressants are lousy treatments for bipolar disorder and may cause more problems than they solve.
The researchers were open, however, to use of anti-depressants short-term, followed by discontinuation. That assumes someone can discontinue the meds, however.
Here's the core assertion from the article:
"Although antidepressant drugs remain the mainstay of treatment for unipolar major depression in both primary and secondary care settings, the evidence to support antidepressant treatment for bipolar depression is limited and increasingly controversial—especially now that evidence is available for alternative medications, including quetiapine and lamotrigine."
I'm not sure if they'd want to lean on Seroquel and Lamictal quite that hard since both drugs have serious problems of their own. No matter, it's nice to see a growing consensus among researchers that anti-depressants aren't a good clinical strategy for addressing depression in bipolar disorder. I hope this bit of news trickles out to the clinical world and the market share of these drugs--about 20 percent of anti-depressant sales are to people diagnosed with bipolar disorder--drops proportionately.
Affluenza is not a new term and its use as a cause of malaise and depression among some people in American and Western culture is not new either, but here's a Canadian psychologist, Jane Garland, applying it to teen depression:
"'When people have everything in a material sense, they may have perfectionistic expectations and unrealistic goals,' said B.C. Children's Hospital psychiatrist Jane Garland in an interview, following her presentation to delegates at a session on mental health problems in children and youth."'Children keep hearing the message that they can "do anything," but if they are constantly given everything, they may not know how to achieve their goals and when they fail, they may have poor coping skills, and an intolerance for discomfort,' she said."
While the article never successfully ties "affluenza" to teen depression and Garland doesn't offer hard evidence (then again, how would you construct the study?), it makes a certain amount of horse sense that materialism is hooked in with environmental factors that can affect depression. This is true of adults as well. Not a big surprise. So is anything else new here?
But then is affluenza any worse for teens today than, say, 30 years ago? I doubt it. Maybe the terms of the game are different now, but I think teens have long had--and this may go all the way back to ancient times for all I know--an "intolerance for discomfort." If we weren't being told we could "do anything" in the 1970s and 1980s, I can assure you that the cultural message was pretty clear that we were expected to do better than our parent's generation.
Teens have always been in the awkward position of trying to sluff off their childhood psychological make up and trade it in for one from the adult tribe. That kind of transition and change is depression's playground. It'd be interesting to know if Garland (and thank God her first name isn't Judy) had any thoughts on differences in teen depression between various income groups because there are vast differences in who gets what materially out there in the teen world. Is affluenza higher or lower among low-income teens or high income teens?
Anyway, Garland's prescription for all of this isn't to dope the teens on anti-depressants or take away their iPods and BMWs. Exercise, sunlight and peer counseling are what she recommends. Smoothies with Omega-3s (something parents have time to make every morning I'm sure). Screening for pot use (that ought to be a fun conversation). Interestingly, she doesn't say a thing about taking away access to materials good or pressing teens to work in order to achieve them. And, I kind of thought that was her point to begin with--or part of it.
Fuller Torrey, the so-called world's most famous psychiatrist, has a new book out called The Insanity Offense. It was reviewed last week in the Wall Street Journal by Paul McHugh, a psychiatrist and university distinguished service professor at Johns Hopkins. I have no idea what McHugh is distinguished as, but he certainly provides no service in his review of the book wherein he proclaims Torrey akin to an Old Testament prophet who details "murder after murder" committed by the seriously mentally ill who weren't taking their meds.
That's one of the most offensive uses of prophet and prophecy I've ever encountered. While I'm typically sanguine about the excesses of some psych researchers, there is something special about Torrey and his breed of ambulance-chasing advocacy. I've written about him and his group, the Treatment Advocacy Center, many times, often about how the group twists statistics, ignores competing evidence and lies to the media in order to make people diagnosed with schizophrenia appear more violent than the general population (here's my mentions of Torrey, especially the entries from 2006). What's astonishing to me is that the media--and by media I mean the Washington Post, WSJ and New York Post, who regularly quote Torrey or give him op-ed space--continues to buy his brand of BS. Ever more amazing is that I know psych researchers who have openly told me they consider Torrey "evil" but won't say so publicly.
I've not read Torrey's book and don't know if I will, but McHugh's review is worth commenting on itself. Interestingly, like Torrey, McHugh blows off the thousands of deaths tied to the very meds Torrey--and one presumes McHugh--is pressing the seriously mentally ill (and by that phrase Torrey usually means schizophrenics) to take and pressing society to force them to take. What's more, McHugh never seems to have heard of crimes committed by people who were actively taking meds.
I generally think that psychiatrists who actively evade the problems with these medications or tell the public that they are risk-free propositions need to go take 30 mgs. of Zyprexa for 30 days and get back to me on how they feel then. Or, if they prefer old school meds, the injectable Haldol.
The book is, of course, an "expose" of deinstitutionalization and how psychiatry failed the nation by allowing people to be released from state hospitals from the 1960s through the 1980s, leading to crises of homelessness and prison time for people with mental illnesses. Torrey (and McHugh) believe that both problems would be solved by forcing people diagnosed with schizophrenia to take a nice whomping dose of Zyprexa. The number of people I've seen on the streets of Seattle who are taking their meds might argue against that formula, but homelessness is easily solved with or without forced meds: by building some damn housing.
Questions of incarceration are trickier, but they don't just boil down to a prevent-crime-take-Risperdal formula. As I noted above, there are plenty of folks who do crimes while taking meds. There are instances where the meds themselves are intimately tied to the commission of crimes.
But this is what makes my blood boil:
"What is to be done? 'The Insanity Offense' calls for a restoring of some central state responsibility for these patients in ways that would permit monitoring them regularly, keeping them on their medications and insisting on a protected-care setting if they relapse. It is not necessary to reopen all the old state hospitals: The programs that are needed could be carried out in clinic offices with backup, shorter-stay hospital beds."Torrey points to successes in a few states. He particularly endorses a program in Wisconsin [PACT/ACT] that provides outpatient tracking and regular medication treatment along with resources for ready involuntary commitments when either treatment fails or the patient becomes unable to control behavioral outbursts.
"The issue is whether the public can be rallied to support these reforms. One obstacle: Legions of lawyers are opposed to such changes, claiming that they are infringements on 'civil liberty.' More than a few such lawyers are heard to proclaim that the violence and murder committed by mentally ill people are 'the price we must pay for democracy.' Here is idolatry of the most blatant kind -- with human sacrifice, no less -- and hence our need for the fury of a prophet."
The reality that the Torrey/McHugh crowd regularly ignores is that the Constitution does not create second class citizens known as the seriously mentally ill. Their rights are pretty much the same as anyone else's--and yes they do have civil liberties, as the courts have found on numerous occasions. Civil liberties are not some kind of joke that merits quote marks.
What's more, McHugh is grandstanding in a way that's not befitting an academic. In searching Google, I can find no instances of any lawyer proclaiming mayhem committed by the seriously ill are "the price we must pay for democracy."
McHugh's review is so off-base and poorly argued that it hardly makes the case for putting up with Torrey's book.
Every so often one of these sad stories crops up: a guy goes off and commits a sexual assault--almost always against a woman--and tries to use a diagnosis of bipolar disorder as a defense. I think that the defense is stupid unless someone is clearly psychotic or manic, in which case they'd likely clear the hurdle for not guilty by reason of insanity.
In this case, a Massachusetts state senator isn't manic at all. He's hypomanic and allegedly recently went off and groped a woman. I've never heard of trying to invoke the bipolar defense based on hypomanic symptoms, but I guess in politics anything flies these days. From the Boston Herald:
"State Sen. James Marzilli, accused in a string of sexual assaults, could be laying the groundwork for a defense based on a diagnosis of bipolar disorder - a mental illness marked by wild mood swings that causes victims to lose control of their impulses, according to sources close to the Arlington Democrat."Marzilli continued to receive treatment yesterday at McLean Hospital, a psychiatric facility where he is expected to remain at least through the weekend. The 58-year-old senator checked into the hospital after he was accused of trying to grope a woman in downtown Lowell. Sources said Marzilli is being treated for hypomania caused by bipolar disorder."
I somehow have a hunch that a judge or jury would have a tough time with such a defense, as they should. I'm not sure that anyone could establish that hypomania removes one from their obligations to others in society--that would include not assaulting them--and that thy aren't able to discern between right and wrong.
What do you think?
I never thought I would read these words in the New York Times concerning anything to do with mental health.
"Ramona Lamascola thought she was losing her 88-year-old mother to dementia. Instead, she was losing her to overmedication."
OK, I'm being a bit rough there (the Times essentially made that point in its Zyprexa coverage after being over the top defenders of the psych faith for years), but now the paper of record has discovered the wild overmedication of the elderly in nursing homes, many months after the Wall Street Journal, St. Petersburg Times and CBC took it on, and well after I started hammering on the use of antipsychotics for dementia and their connection with sudden deaths and so on. But now that the Times has gone after it, they've done a good job.
"[M]any doctors say misuse of the drugs is widespread. 'These antipsychotics can be overused and abused,' said Dr. Johnny Matson, a professor of psychology at Louisiana State University. 'And there’s a lot of abuse going on in a lot of these places.'"Dr. William D. Smucker, a member of the American Medical Directors Association, a group of health professionals who work in nursing homes, agreed. Though the group encourages doctors to conduct a thorough assessment and prescribe antipsychotics only as a last resort, he said, 'Many physicians are absent without leave in the nursing home and don’t take an active role in the assessment of the patient.'"
It goes from there with more doctors criticizing the use of antipsychotics--now a $13 billion market after being only a $4 billion market in 2000--and Janssen/J&J defending its marketing of Risperdal, an atypical antipsychotic that's the subject of lawsuit by the State of Arkansas over how the company allegedly marketed it for use in nursing homes.
"Ambre Morley, a spokeswoman for Janssen, the division of Johnson & Johnson that manufactures Risperdal, would not comment on the suits, but said: 'As with any medication, the prescribing of a medication is up to a physician. We only promote our products for F.D.A.-approved indications.'"
I wish the company luck with that line of legal argumentation in court. No quotes from Lilly in the story even though the company faces several similar lawsuits.
The paper even notes why so many studies show that dementia patients do better on placebo than on antipsychotics.
"Some doctors point out that simply paying attention to a nursing home patient can ease dementia symptoms. They note that in randomized trials of antipsychotic drugs for dementia, 30 to 60 percent of patients in the placebo groups improved.'That’s mind boggling,' Dr. [UCSD psychiatrist] Jeste said. 'These severely demented patients are not responding to the power of suggestion. They’re responding to the attention they get when they participate in a clinical trial. They receive both T.L.C. and good general medical and humane care, which they did not receive until now. That’s a sad commentary on the way we treat dementia patients.'"
Yes it is. And the story has more, including how Lamascola got her mother back.
And, if it's not clear to anyone, let me point out that the way the antipsychotic market got so big so fast was mostly on the backs of people diagnosed with bipolar disorder and dementia--the market for schizophrenia had mostly been tapped for atypicals by 2000--and that's just wrong. It's time doctors took a hard look at how they are prescribing these pills to so many people. They aren't working out so well.
A British company called Psynova has announced a financing deal with a Texas-based company called Rules-Based Medicine, all of it to bring to market a biomarker blood test for schizophrenia. In other words, this is a gene test and I am very suspicious of gene tests for several reasons, primarily due to the opportunity for discrimination (in just about every way imaginable) and because it's not even clear how much genes determine whether someone gets schizophrenia, or any mental disorder for that matter.
The UK Business Weekly thinks things are rosier though.
"Psynova plans to push the diagnostic test out as a research tool for scientists investigating schizophrenia before hitting a wider market with a clinically approved product with the potential to transform treatment for sufferers."
I'm sorry but how would it transform treatment? By enabling doctors to force meds on people sooner so we can watch the rotten results of the PRIME study play out on a culture wide level? By giving doctors a form of "evidence" they can take to a judge to get a court order to force someone onto Zyprexa who isn't a danger to anyone? Will we force it upon small children who act out in class? You've got to wonder. Anyway, I doubt these sorts of gene tests being bandied about for various mental disorders will prove out in the real world, but I am a skeptic by nature.
According to the above article, Psynova plans to also roll out gene tests for bipolar disorder and depression. I've taken up the question of bipolar blood tests and depression gene tests previously.
The only thing this deal and test have going for them is that it allows me to point out that that Sabine Bahn, a psychiatrist and Psynova co-founder, is the hottest psychiatrist in human history. You can see her picture at the first link above.
John Grohol at Psych Central has begun an interesting new feature--interviews with various muckety mucks in the psych world. First up is Phil Ninan of Wyeth, which recently released Pristiq, a metabolite of soon-to-go-off-patent Effexor, and is marketing it as an anti-depressant.
Grohol asked Ninan about withdrawal problems potentially cropping up with Pristiq:
"Pristiq being an active metabolizer effecter and also having a fairly short half-life, we would expect would have the potential to discontinuation symptoms. And that is exactly what we have found in our clinical trials."
Actually, Ninan refuses to count what most of us would call withdrawal symptoms as withdrawal. He calls it discontinuation. That's bull shit semantics if you ask me, but here's his explanation:
"I think, one should distinguish what is a withdrawal syndrome from what we would call discontinuation symptoms. Withdrawal is traditionally associated with medicines that one has got physiologically dependent on. And there is a whole set of not only symptoms, but physiological changes that occur that can be potentially dangerous."You see that with alcohol, you see that with benzodiapams, the anti-anxiety and sleep medications that can cause physiological dependence. And you see that with pain medications, particularly opiates and that class of medications. So, those can be medically problematic and potentially dangerous in some people."
Oh, and it's not dangerous when the same thing goes on with Effexor and Paxil and other psych meds? Whatever, dude.
My article on researcher Erick Turner's paper on unpublished anti-depressant efficacy data and what that meant for the class of drugs was reprinted in the Missoula Independent last Thursday. It originally ran in Willamette Week in April, so if you missed it the first time out, check it out.
One of our greatest comics of the last 40 years died last night, aged 71. I loved Carlin, especially when I was a teen, because he was pushing stuff that no one else would touch. Except for Richard Pryor, of course.
Anyway, the guy could rant like no one else and here's a fairly recent rant on stupid Americans (I couldn't find a YouTube of the 7 words). Like most of Carlin's material, it's filled with obscenities, so careful if you are at work.
Like Pryor, the loss is immense.
You read that headline right. Kenny Handleman, a doctor who writes the ADD/ADHD Blog, fears that ADHD criteria in the current DSM are too restrictive and preventing adults for being diagnosed with adult ADD. Personally, I cannot think of a single time in the history of the DSM that loosening diagnostic criteria for a condition actually wound up serving patients as opposed to doctors and pharma companies, but here's Handleman's take:
"[H]aving to have symptoms before the age of 7 is often limiting. It is problematic, because it is often hard to establish this early history in an older adult. New research is showing that the age of onset is also too restrictive (this paper cites two new research papers which challenge this criterion)."Another criticism is that the description of impairment is done from the perspective of childhood ADHD and is not appropriate for the impairment that adults with ADHD experience. Furthermore, the diagnostic threshold (i.e. 6 out of 9 symptoms) doesn’t reflect several lines of research which document that adults with fewer symptoms are still quite impaired from their ADHD.
"The DSM-V is due out in 2011. Many researchers are working to improve the DSM criteria for adult ADD/ADHD. This is particularly needed because many doctors are not comfortable with the diagnosis of adult ADHD, and they need to have diagnostic criteria which will help them to diagnose this condition more easily. Also, new research has shown that 4.4% of American adults have ADD/ADHD. So there is a lot of need out there, and ‘new and improved’ DSM criteria are needed."
While the ins and outs of adult ADD and ADHD are a bit out of my wheelhouse, I do worry about 10 million or so Americans being slapped with a newish disorder and being pressed to take stimulants (you can bet therapy won't be pushed). But, then, they are adults, so they do have the ability to opt in or opt out of treatment.
What do you think?
As part of its rehabilitation efforts for a drug the FDA didn't approve earlier this year, Lilly released a new set of data for its long-acting injectable today. I have nothing to add, except that I truly feel awful for anyone who ends up on this drug, which will likely be approved by the FDA at some point.
Thanks to all of you who gave me feedback on when you read my site. There's enough of a spread in when people read that I think what I am going to do is continue to make sure that I have at least one fresh post up by midnight each evening and do the rest throughout the day, as opposed to my more common pattern of everything in the evening. The weather is finally getting warn enough in Seattle to where the evenings are mostly enjoyable and I'd like to enjoy them.
Anyway, we'll see how this works.
I've been noting for some time now the rise in studies of anti-depressants for treatment of pain, the increased use by pain management docs of anti-depressants for pain treatment and the recent approval of Cymbalta for fibromyalgia. I'm fairly dubious of anti-depressants for pain--the studies seem to overstate treatment efficacy and what I hear from the patient world doesn't detract from my doubts--but then I am fairly dubious of how effective anti-depressants are for depression. Studies like this new one, led by a Lilly researcher, sure don't make my doubts seem too misplaced.
The study was of how Cymbalta worked in treating knee pain, or osteoarthritis, and had some interesting results:
"Duloxetine [Cymbalta] showed statistically significant improvement in pain associated with osteoarthritis of the knee according to the primary efficacy measure of mean 24-hour average pain scores. Fifty-nine percent of duloxetine-treated patients experienced a 30 percent improvement in pain compared with 45 percent of patients taking placebo. Forty-seven percent of duloxetine-treated patients experienced a 50 percent improvement in pain compared with 29 percent of placebo-treated patients."
That's an effect size of 14 percent, which is truly unimpressive, but I bet the FDA would approve the anti-depressant for knee pain. And there's no way Lilly would've shelled out money on a clinical trial if it weren't going to pursue an indication for knee pain. Unless this data is part of the company's recent application to have Cymbalta approved for chronic pain. Anyone of my readers at Lilly want to clarify this for me?
Soon enough we shall have a knee pain treatment with a black box warning for suicidality. How weird.
Hi all. The drop off in reader traffic that comes each summer is just beginning this week, and I wanted to ask you all a question so I can figure out how to schedule my posts during the summer. At this point, I'll largely be writing for regular readers, as looky-loo traffic drops in the summer, so what time of day do you read this site or check your feeds or bookmarks for updates? Let me know in comments please. For the sake of consistency either let me know what time zone you are in, or convert your local time to PDT.
And, thanks to all of you for the many comments on this site. Yesterday, I hit 10,000 comments on this site. That feels like a milestone.
This is just up on the excellent WSJ Health Blog. The news is that the FDA got left out of some of the documents around suicidality data on Paxil. From the paper's Alicia Mundy:
"Here’s how things went down. Plaintiffs attorneys in Los Angeles got permission last year from Glaxo’s defense team to give the Justice Department (at DOJ’s request) access to a ton of confidential material, including the right to discuss details about it all with the plaintiffs lawyers. Glaxo had insisted previously on having them sealed in Federal Court."Several months later, when the plaintiffs lawyers at Baum Hedlund asked for permission to give the same stuff to the FDA, Glaxo’s defense team balked.
"On Oct. 15, 2007, Glaxo’s outside lawyers at King and Spalding in Atlanta said that the FDA had already looked at Paxil and suicide, and therefore, they wrote, 'If the FDA wanted additional information, such as the internal documents you propose providing it, they could have requested them from GSK.'
"That prompted Baum Hedlund’s Skip Murgatroyd to tell the Health Blog, 'How the heck can the FDA ask for information they don’t have, when they don’t know about it?' Fair point. An FDA official, who asked for anonymity, said the same thing to the Health Blog when we read the letter to him."
There's more to this, so go read it. As a journalist, it's interesting to me that the Journal is all over this story while the New York Times is virtually silent.
The Wall Street Journal has a piece in today's issue--and I can only get a snippet of it on this side of the subscription firewall--stating that the feds are widening their probe of allegations that GlaxoSmithKline hid suicidality data on Paxil for 15 years. From the paper:
"A Justice Department investigation of GlaxoSmithKline PLC's handling of its blockbuster antidepressant drug Paxil, including its marketing and safety research, appears to be widening."Glaxo, one of the world's largest drug makers, confirmed Thursday that a previously disclosed Colorado-based Justice Department investigation of marketing practices also includes the Boston U.S. attorney's office and is being coordinated by the agency in Washington."
Reuters thought the piece significant enough to run an account of it on its wire. From this, you can tell that several arms of the Justice Department are looking into matters and that's not happening for nothing. The feds don't discuss ongoing investigations, but it's clear that something is afoot. What's more, Glaxo has got Sen Charles Grassley (R-Iowa) poking around the same issue as well.
I'm not sure where this is all leading, but I can assure you that people like these don't waste their time on an issue like this unless they are going someplace with it and there are lots of documents floating around.
Stay tuned.
I wasn't aware of Michael Merzenich's website before yesterday, but he popped up on my radar when he took a swing at the bipolar child paradigm. Merzenich is an emeritus professor of neuroscience at UCSF, is an expert on brain plasticity (a very important end of the neuro world) and runs a company called Posit Science, about which I know nothing. I'd say the guy has some substantial academic chops (here's his list of publications) and so it was nice to see him offer the following:
"This is an arena in which medical school-based researchers like Dr. Biederman and his colleagues can really play a key role. For kids with severe emotional problems,this team does not appear to have tested a drug that they did not really like. Risperidone, olanzapine, aripiprazole, atomoxetine, bupropion, divalproex, ziprasidone, et alia. They ALL worked. In real life, add an anti-psychotic drug to an anti-depressant and an anti-ADD drug with an anti-convulsant and anti-anxiety meds and maybe a drug or two to slow down the weight gain from the anti-psychotic and to offset the side-effects that emerge from the anti-convulsant…"Think I’m exaggerating? This is EXACTLY the kind of drug stew that I recently discovered was being given to a young 14-year-old girl that my family has known for years. 5 powerful drugs (anti-psychotic, anti-depressant, anti-anxiety, anti-ADD, anti-convulsant, plus 2 to treat side effects). Her malady: Difficulty over a several month long period in completing her homework; ultimately, great difficulty and reluctance about going to school.
"Such a treatment, in such a child, is just plain nuts. The brains of hundreds of thousands of children out there are now being given powerful drug cocktails like these. It’s a beautiful thing, for almost everyone concerned: child psychiatrists have busy clinics; drug companies have healthier bottom lines; hyperactive out-of-control children are brought under control, iand hypoactive children wake up, in large numbers, and their parents are certainly happier for that; and this industry has prospects for still greater (perhaps even accelerated!) growth. As for the child and her/his (their) brain(s), and its(their) future(s)…….."
Precisely. There's more so go read it, including the story of how he didn't hire someone from a pharma company because she'd shown up at UCSF to browbeat some researchers into deleting a certain paragraph from an article.
I, for one, am thrilled to see the neuro crowd starting to poke at the psych world. It's much needed.
That's the finding of a study unearthed by psychologist Bruce Levine.
"Medical records of 105,335 pregnant women enrolled in Tennessee Medicaid from 1999-2003 revealed that antidepressant use during pregnancy increased from 5.7 percent in 1999 to 13.4 percent in 2003."
Obviously, that's data from one state and from one state's Medicaid program, where the prevalence of severe depression and anti-depressant use is bound to be high, and doesn't account for anti-depressant use by pregnant moms in private health care systems. All those caveats aside, it's still a startling finding and makes you wonder what things are like in 2008 and what kind of prevalence there is nationally.
Assuming that 13.4 percent rate is good for the US as a whole, then a hell of a lot of pregnant women are taking anti-depressants in the US. There were 4,265,996 live births in the US in 2006, according to the CDC. That would work out to 571,643 women taking anti-depressants while pregnant using the 13.4 percent rate. Even more eye-popping to me is that the rate almost tripled in four years. Levine also notes that "in another study of pregnant women treated at seven health maintenance organizations (HMOs), American Journal of Obstetrics and Gynecology reported in February 2008 that 'antidepressant use in pregnancy nearly quadrupled from 1996 to 2005' and that nearly 8 percent of pregnant women used antidepressants in 2005."
There are all sorts of issues tied up with anti-depressant use during pregnancy, but being a a man I'm not sure how comfortable I am trying to sort them out. Read Levine's piece for that.
Speaking of Levine, yesterday he took on the whole business around recent revelations around Harvard child psychiatrists.
Last week, the CDC released mortality data for 2006 to very little fanfare. It showed that deaths were down in the US, rather sharply too, and that suicides went down by 2.8 percent. The numbers are preliminary, based on 95 percent of death certificates for the year, and final numbers won't be out until sometime next year. We don't have a final number for 2005 yet either--that should come later this summer--but based on early figures released last September, in 2005 the suicide rate was 10.6 per 100,000, so 2006 should check in at something around 10.3 per 100,000. That's a decent drop from 2004's 10.9 per 100,000, but it's kind of hard to draw too much encouragement from it, since it's within the sawtooth pattern of about 10 to 11 per 100,000 that's marked the suicide rate for about a decade.
But a drop is a drop.
It's interesting that no one in the anti-depressant defender community has picked up on this yet and made the argument that anti-depressants are responsible and, therefore, we should all take 'em. Perhaps they are still busy touting dubious data on 2004 that they claimed shows a drop in Rxs that year--the drop was actually in 2005--drove the rate upwards. Or maybe they are still trying to reconcile themselves to the fact that a drop in Rxs in 2005 came at the same time that there was slight dip in anti-depressant use that year which kind of shoots holes in their argument. Or maybe they are still reading the British study from earlier this year establishing that anti-depressant use and suicide rates are independent events. Who knows?
Either way, the US is not even in the ballpark of meeting the national goal of cutting its suicide rate to 5.5 per 100,000 people by the end of 2010, a goal that was set by HHS in 1999.
ABC News reports that at least three US Reps are calling for an end to tests of the stop smoking drug Chantix, which has been linked to erratic behavior in some vets in the VA-administered study. Reportedly, the VA knew of problems with the drug but did nothing to warn much less monitor the vets in the study.
I'm sure we've not heard the last of this odd moment in medical research at the VA, nor of problems with Chantix, which has become the Paxil of smoking cessation drugs.
A new study is out today in JAMA asserting a link between type 2 diabetes and depression and vice-versa. The study now joins reams of studies in recent years--many of them by non-psychiatrists, just to be clear--that link depression with seemingly every human malady and shortcoming. Heart disease, cancer, obesity, chronic pain, racism, poverty, smoking and so on have all been tied in with depression, locked in the kind of bio-psychological feedback loop that has doctors calling for depression screening and the inevitable push for treatment with anti-depressants (which themselves have been linked with diabetes causation in some studies just to make things even more confusing) and me scratching my head over what it all means. Because it does all mean something. And maybe nothing all at once.
I'm not trying to minimize these kids of well-meaning studies, but is it possible in this day and age of doctors micro-managing human existence and marching us all off to our neighborhood pharmacies, allegedly to make us feel better, to say that when people are sick, especially with chronic illnesses, that there's a likelihood of some depressive symptoms because that's just the nature of life and the nature of life is kind of depressing? Especially when you are sick.
In the diabetes study:
"People being treated for Type 2 diabetes, the most common form, were 52 percent more likely to develop depression than those without the disease...."The study adds to a growing body of research showing a link between depression and diabetes, researchers said. Doctors may want to consider screening those with diabetes for depression because it may affect how well patients follow recommendations and their risk of developing complications of the disease, researchers said."
The basic findings were that 14.4 percent of people with type 2 diabetes had some symptoms of depression while 11.7 percent of people in the study without diabetes had some depressive symptoms (and that rate for the latter group is well above the generally accepted 6.7 percent NIMH number for depression in the general population). Whether the diabetes was driving the depression or vice versa isn't clear (I'm sure there's data pointing in both directions), but confoundingly only 7.4 percent of study patients who had untreated diabetes had symptoms of depression. That's roughly half the rate of depression in people being treated for diabetes, which kind of makes you wonder a bit about the nature of diabetes treatment and about the power of psychological suggestion of treated versus untreated states.
That's not an argument against diabetes treatment of any kind. I'm just pointing out that not all of the pieces fit as conveniently as the many news accounts of this study would lead you to believe.
But let's assume for a moment that all of these depression linkage studies are rock-solid truth. Is the implication that anyone with diabetes or heart disease must also get an anti-depressant? Would that make sense for a treatment modality that works about 30 percent of the time and comes with the potential for a host of gnarly side effects? What about with chronic pain, where I'd judge the depression relationship to be very strong? Do you treat the pain or the depression? The way the DEA and some state health departments have gone after the use of painkillers now means that many, many people with chronic pain are being forced into using anti-depressants to treat the underlying pain (and some anti-depressants are approved for various pain indications) with very mixed results both in treating pain and depression. Is this a good thing for us as a culture?
I don't pretend to have the wisdom to sort these kinds of questions out beyond observing that maybe patients should be fully informed of what they are up against and what the pros and cons are of anti-depressant treatment, leaving them to arrive at their own answers for how to treat their own bodies and moods. This is America after all.
And, as far as wisdom goes, I find studies such as the JAMA one to be singularly lacking in wisdom, despite their very interesting and very conflicting data. Onward marches medical science.
Ed Silverman at Pharmalot has an interesting interview today with Alison Bass, formerly a reporter at the Boston Globe, who's dug into the epic story of bad medicine and deceit that is the Paxil story and written a book called Side Effects: A Prosecutor, A Whistleblower and A Best-Selling Antidepressant on Trial.
Here's a snippet:
"Pharmalot: What was the most surprising info you came across while researching the book?"Bass: What I found most surprising was they doctored the research on the Paxil study. When I looked back at memos I received from the Institutional Review Board from Brown, teenagers were withdrawn from the study and called non-complaint when they were in suicidal as a result from Paxil and should’ve been counted in the study as adverse effects. If these had been appropriately coded, there would have been an even greater risk of suicidal effects from Paxil. That was really amazing. There were many indications this Paxil study, it was called study 329, was doctored. But because it was published in a prestigious medical journal, Journal of the American Academy of Child & Adolescent Psychiatry in 2001, doctors paid attention."
I've covered the Study 329 nonsense previously. Bass also has her own website, which is here.
The Washington Times and ABC News have teamed up on an investigative report in which it's revealed that the VA has been enrolling Iraq vets and others as research subjects for drugs with dangerous side effects. Case in point: one vet with severe PTSD was placed in research for Chantix, Pfizer's star-crossed stop smoking drug, and completely lost control of himself and almost lost his life in a confrontation with police.
"Within a few weeks of his [James Elliott, former Army sniper] taking Chantix, VA officials learned the drug was causing serious side effects across the nation, including psychotic behavior, suicides and suicidal tendencies. But the agency took three months to get that warning through its system and to the veterans in the study."Night after night, Mr. Elliott violently thrashed against the plush toys in his sleep, shouting for air strikes, replaying the horror of watching friends bleed to death."
You have to wonder how widespread this sort of thing is within the VA and how much money the government is making in the bargain.
I know there's a place for the vets and the VA in research, but Chantix doesn't exactly scream "life saving cancer treatment" and you wish the VA would be a bit more selective in choosing who goes into what research projects. And, what kind of follow-up there is relative to side effects.
Then again, the military does have an odd history of testing substances on soldiers, with or without their knowledge such as famous episodes involving LSD and Agent Orange. Those are inexcusable, the Chantix episode is merely highly questionable.
Over the weekend, there was a long, discouraging article in the Austin American Statesman detailing the unexplained death of a young Marine from Texas at Twentynine Palms, Calif. He'd been taking a host of meds for PTSD, including Seroquel and Prozac. The story is far too depressing to recount in its details.
But this is not the first time that there's been unexplained troop deaths involving Seroquel and anti-depressants.
Last month, a report out of West Virginia identified four recent deaths of Iraq War vets who similarly died in their sleep.
"Military doctors prescribed Paxil, Klonopin and Seroquel for Johnson, the same combination taken by veterans Andrew White, 23, of Cross Lanes; Eric Layne, 29, of Kanawha City; and Nicholas Endicott of Logan County. All were in apparently good physical health when they died in their sleep."
While each of these cases likely has differences, they bear enough similarities that I hope someone at the VA or Department of Defense is looking into these and other cases and trying to figure out what is going on. Before this happens to any other troops. Something is falling apart in the chain of medical treatment for these folks.
Our people simply deserve far better than this, especially after putting their butts on the line for this country for several years. It should be an especially important issue for the military, given recent reports of just how much we are medicating up troops for psychological issues and then sending them back into action. If this is the outcome of the "help" we are giving our military, then perhaps we need to look into other solutions.
I've said before that, regardless of what you think of the Iraq War, we will paying the price for President Bush's stupidity for years to come. This is one time that I'd prefer to be wrong, but fear that I won't be.
Last week US News & World report had a fascinating Q&A with Larry Diller, clinical professor at UCSF who practices pediatric psychiatry in Walnut Creek, Calif. (oddly enough, the town I was born in). Diller is a semi-controversial figure in child development circles for his book Running on Ritalin and for his harsh criticism of the bipolar child paradigm. This time out the subject was spanking kids and Diller offered some interesting thoughts.
"Q:Spanking is probably the most controversial issue in child rearing. You treat children with ADHD. What on earth compelled you to write that spanking may not be so bad?"A: I was provoked. About a year ago, a California assemblywoman from the South Bay put out a proposal to make the spanking of children 3 years old and under criminal. I thought, please, please! The reason it gets to me is that in 30 years of practice as a developmental pediatrician, issues of discipline cause 80 percent of the problems that I see. The families that are struggling with children's behavior are also struggling with spanking. Often, they've taken a vow of abstinence. They figure if spanking is bad, then all forms of conflict are bad, and they hesitate to discipline their children. They wait too long before taking effective action. This doesn't have to be spanking; it could be removal of a toy or imposition of a timeout. I am talking about middle-class, upper-middle-class families that love their kids, that have the resources for their kids.
"What gets children into trouble early on are qualities of temperament—qualities of persistence and intensity. These kids have determination, stubbornness—a simple no doesn't work. Even a "Boo!" doesn't faze these guys. The other quality of temperament that comes into play is intensity. When the child is happy they're very happy, but when they're angry they're very angry."
I largely agree with Diller, for what my wee opinion is worth. Since physical discipline has gone out of schools and families over the last 30 years, we've seen an epic rise in the medicating of small children, or "chemical swaddling," as one of my friends at The Icarus Project calls it. Kids are being doped up for behaviors that a generation ago would've gotten them a spanking and a timeout. Now, they get Seroquel and Adderall and researchers at Harvard get rich. And, then the obvious question came out:
"Q: Aren't you worried that parents will say: Larry Diller says if I spank my kid, he won't get ADHD?"A: That is my big worry. And that's why my friends tell me to keep my mouth shut. To say that all ADHD kids should be spanked is a misreading of my position. But I expect parents and schools to do something before we give out pills. And I give out pills.
"What we overlook is that in mild ADHD, which is the majority of the ADHD that is diagnosed in the community, a more organized and coherent system of discipline can make the difference in whether your kid will be on Ritalin or not. You don't have to spank. But if you're using spanking as one of an array of tools to get control of your kid, you're not hurting them in the long term. Lively, impulsive, spontaneous kids who know when to shut up don't get medicine."
Again, I largely agree with Diller and have written about my own experiences as a kid who, under today's behavioral control systems, would have been medicated into the ground. I'm glad my dad spanked me here and there, I'm glad a few teachers used a firm hand with me as well. I'll leave it at that.
As you might imagine, Diller's views generated some reader responses, so the mag went and chatted up Murray Straus, a professor of sociology at the University of New Hampshire, who is apparently a spanking researcher. I also think he is an out-of-touch loon.
"Q: You've been researching the effects of spanking for almost 40 years, and you think that it's unquestionably bad for kids. Yet many people say that science hasn't proved that it's harmful. Why is that?"A: They take the exceptions. There is 93 percent agreement in the studies that spanking is harmful. It leads to more antisocial behavior in childhood, as well as increased aggression, spousal abuse, and child abuse in adulthood. That's an almost unheard-of consensus in parenting studies.
"I think it's also a human-rights issue. Just as adults have the right to live their life without fear of attack, children should too."
Straus does the usual trick of conflating spanking--by which I mean mild discipline--with beatings. But to frame spanking as a human rights issue is extremism and academic posturing at its finest. He later equates spanking and smoking--smoking has simply become the new bugbear of liberal social criticism--and argues that children spanked by their parents sometimes turn into adults who like to be spanked while having sex, which he views negatively. I'm not sure why that would be offered as a reason to be for or against spanking (I generally think that beyond rape and forced beatings that anyone's choice of sexual behavior is beyond criticism, but maybe not beyond laughter), but he also trots out the argument that former-spankees are basically wife beaters as well.
He doesn't tackle the issue of medicating misbehaving kids, so I haven't the faintest what his views are there. But what bugs me the most about Straus' assertions are that you cannot do surveys of people as adults and peel back the onion of their adult behavior all the way to signal childhood incidents such as daddy spanked me. I know researchers think they can correlate anything with anything and call it peer-reviewed research, but I just don't buy it. Humans are way too complex and human psychology is way too dense to get down to simple causes. In a way, Straus' arguments remind me of the pot causes schizophrenia research that's being tossed about these days--it's typically population-based surveys that cannot correct for all the other environmental and genetic influences that someone later diagnosed with schizophrenia may have had before smoking a joint.
Of course, there are exceptions to all of this. I once knew a woman in San Diego who had seen a kid get run over when she was a child and couldn't ride in a car or drive one without a complete panic attack. As a result, she couldn't drive, her friends refused to drive her anywhere and cab companies wouldn't come pick her up. I have no idea how she had a social life. Once, she got quite ill one evening and needed to get to an ER. She called me. I knew what I was getting into and stuffed her into my car and cranked the stereo. Within moments, she was screaming at me that I was killing people as I drove her--very fast--to the ER. There was sheer terror on her face and it wouldn't have been erased if I'd gone 5 MPH. It was one of the most painful episodes I've ever witnessed with a grown adult. And it all did seem to stem from one brief moment of childhood trauma.
Not that childhood traumas can't have their plus sides. When I was a 10-year-old in the Bay Area, one day I was waiting at the bottom of my neighborhood for a ride to swim practice. It was one of those classic hot-as-blazes July afternoons and some guy came gliding towards me on a Honda 750 SS--yes, I still remember the model--and suddenly some idiot made a left turn in front of him. The motorcyclist tried to brake, but hit the rear of the green Pontiac Bonneville and flew over the trunk. He was wearing only shorts and sandals, not even a helmet, and he slapped against the pavement. I'd never seen anything like this in my life (there was literally blood on the road) and he stood and looked at me--I remember his dark beard and bugged out eyes--and then I looked at his right leg. It was very mangled and there was bone visible and his skin was filleted. He looked down and then looked at me. Before I could run to get help, another driver stopped, got out and wrapped the man's leg in a sweatshirt and stuck him in his car and sped off. Presumably to a hospital. The police arrived. I answered the cop's questions and then my ride showed up. I told my folks about the incident later on, but didn't think about it much even though I recall having weird dreams for a few nights. It was just one of those things you see in life and process somehow.
Ever since that day I have been a hyper-defensive driver, be it of bicycles or motor vehicles. I am always aware that, even if I have the right of way, the other car sitting there, the person standing on the sidewalk, whatever, whomever can screw up and the consequences can be immense. And, so I've never been in an accident. Knock on wood.
And yet I know others like the woman I knew in San Diego would utterly be taken apart by seeing the same thing and need years of counseling.
Maybe the difference was because my father on occasion spanked me. OK, I'm joking about that.
I was just on a conference call with FDA officials wherein the agency announced it was adding a black box warning to first generation--aka, typical--antipsychotics concerning their use in elderly patients with dementia. The label will alert clinicians to "increased deaths in elderly patients with dementia," said Thomas Laughren, head of the FDA's psychopharmacological division.
Previously, there has not been a black box warning on the older drugs such as Thorazine, Haldol and Mellaril, but recent observational studies out of Canada have established there that is a risk of "excess mortality" in elderly patients given these drugs, Laughren said. A somewhat similar black box warning has been in place on atypical antipsychotics relative to their use in the elderly since 2005. Laughren said the FDA does not know what the mechanism is that is causing the deaths and that causes are difficult to identify in patients whose average age is late-80s and who have multiple, ongoing health issues. The deaths are mostly related to cardiac incidents and pneumonia.
The risk of death associated with the older antipsychotics was 4.5 percent in one study versus 2.6 percent in patients on a placebo. Other studies indicate that risk of death in dementia cases is slightly higher with atypical antipsychotics. You can read the FDA's press release here.
I've previously covered issues around antipsychotic use and dementia here.
A few issues have popped up recently around comments on this site and I wanted to get some input from you all so I can hopefully improve things and do it in a way that doesn't annoy the hell out of you.
For one, I've got to get this site's comments more interactive and faster posting, etc., so that I spend less time approving comments (especially during the summer when I'd like to be outside!) and your comments go up faster. Also, the reality is that there are so many commenters and readers these days that it's hard to keep up with it all manually.
To do that, I'd need to go over to an unmoderated system and either installed one of those thingys where you type in code to get your comment approve, or require commenters to be registered with the site. What preferences do you guys have? What have you seen on other sites that works for you, or doesn't work for you?
Beyond that, I wanted to ask how you all have found the tone of comments lately. The reason I ask is that I've heard from some of you directly, complaining that you were feeling cut up by such and such a commenter and while I don't ever expect the Internet equivalent of a tea party in comment threads, I do want to have a site where anti-psychiatrists can talk with psychiatrists and not have it turn into a donnybrook, to use an obvious example. I guess what I'm asking is how do I have a commenting culture here such that open-minded psychiatrists and therapists can be part of the conversation and the patients who dislike the system entirely can respect that they are part of what will create positive change and not cut them to ribbons each time out? Any ideas?
Anyhow, let me have you thoughts in comments and we'll go from there.
The reason for the phenomenon isn't clear from this new study in the Journal of Occupational and Environmental Health, but European researchers found:
"Working overtime was associated with higher anxiety and depression scores among both men and women. The rate of questionnaire scores indicating 'possible' depression increased from about nine percent for men with normal work hours to 12.5 percent for those who worked overtime."For women, the rate of possible depression increased from seven to eleven percent. In both sexes, rates of possible anxiety and depression were higher among workers with lower incomes and for less-skilled workers.
"The relationship between overtime and anxiety/depression was strongest among men who worked the most overtime 49 to 100 hours per week. Men working such very long hours also had higher rates of heavy manual labor and shift work and lower levels of work skills and education."
It's an interesting enough finding, but you have to wonder how it would turn out in the US (are Americans who work OT less depressed that their Euro counterparts?) and what the implications are for regular humans. Work less? Do less manual labor? Get a better education?
Even more, I have to wonder if our shift in America from a manufacturing economy to more of a service economy over the last 30 years has resulted in more or less depression and anxiety. I wouldn't even pretend to know.
I just wanted to let you all know again how much I appreciated your support during the recent fundraiser. I'm almost over my cold--but not before some weirdo commenter came through and attacked me for being so "anti-science" that I wouldn't take cold meds--but I took it easy last night and hope to play some catch up later this morning.
Until later, consider this editorial from the New York Daily News on what they want to see come into effect with forced medication laws in New York State. As well as this article on a database that would track the mentally ill in the Empire State. Or maybe that should be vampire state.
The Boston Globe had an interesting blog item yesterday pointing to a statement issued by Mass. General. In it, Peter Slavin, president of MGH, and David Torchiana, chairman and CEO of Partners Health Care, which is connected with MGH, defend the Harvard child psychiatrists recently outed as having significant financial conflicts and, shall we say, financial reporting problems as "beloved and trusted by thousands of grateful children and families" and "pioneers in the field of child mental health."
While you'd expect some kind of PR response similar to last year's defense of Biederman, et al., you have to wonder what the folks at Harvard don't get about the criticisms they are facing for their deep ties to pharmaceutical companies and their research. At a minimum, to try and toss off the defense that these relationships are well managed when there are epic discrepancies all over the place strikes me as the death cry of an institution or sheer naivete. Take your pick.
From the Mass. General statement:
"First, we want to state that MGH firmly believes that appropriate and closely managed collaborations between academia and industry are important in the ongoing quest to discover treatments, cures and preventions for diseases that afflict millions of people worldwide. The innovative work of scientists at institutions like the MGH provides the intellectual and scientific foundation for so many of the therapies that industry has developed, tested, manufactured and carried to the marketplace to benefit patients."Second, we want to emphasize that the three MGH physicians being reviewed have all been vital players in such productive collaborations with industry. Their impressive body of academic work, backed up by significant data and rigorous science, has earned them reputations as international leaders in the understanding and treatment of serious pediatric psychiatric disorders. Perhaps most important, they are beloved and trusted by thousands of grateful children and families who have counted on them for treatment, counseling, help and hope. We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them."
Their hearts go out to them? Rigorous science? Sheesh.
Sen. Charles Grassley (R-Iowa) is sure turning into a one-man problem for Big Pharma. Today he's calling on the FDA to take a look-see at Glaxo's data on Paxil safety.
"The British counterpart to our country’s FDA found that GlaxoSmithKline withheld important safety data on Paxil," Grassley said in a statement. "If the company engaged in this behavior in the UK, then I want to make sure that the same didn’t happen here in the US. The FDA should investigate this question thoroughly and be forthcoming about its findings."
This push relates to revelations earlier this year that GlaxoSmithKline hid data establishing links between its anti-depessant and suicide as far back as 1989. It'll be interesting to see what the FDA finds. (Via Pharmalot.)
I'd planned several fresh posts for today, but my lingering cold has kicked in fresher than ever, so I am going to be smart and not work myself into the ground. I'll see how I feel later, but for some reason I simply cannot put thoughts into sentences while zonked on cold meds, my head filled with snot. Why I can write when I am depressed (and I have before) but not when I have a cold beats the hell out of me. Then again, medical science has had about as much luck "curing" the common cold as it has depression. Not that there's a connection with that and writing.
Anyway, there is news out there and I hope to have some of it online later in the morning, PDT.
Thanks again to all of you for the success of the fundraiser.
I am sitting at home with my head cold resurgent, but wanted to briefly let you all know that the fundraiser has reached its goal of $2,500 which brightens my mood considerably. Now if it could only drive the snot from my head.
Thanks to all of you for your support and readership. I am humbled.
As of last night, the spring fundraiser stands at $2,350 and I thank the 59 readers who have donated, or in a few cases pledged, to date. That leaves the fundraiser $150 short of its $2,500 goal by the end of today.
I'd appreciate it if any of you who haven't contributed so far would make a contribution today so that this fundraiser can end successfully--not that it's not a success already--and I'll go back to charging forward on the issues we all care about.
As usual, the PayPal button is on the right. If you prefer snail mail, send me an email and I'll shoot you a mailing address.
Thanks to all of you who support my work here. It is all very humbling.
A fascinating bit of research in JAMA came out yesterday in which researchers looked into whether there were benefits to treating kids diagnosed with ADHD with St. John's Wort as opposed to treating them with a placebo. The study involved only 54 kids, so it's not what I'd call high-powered statistically. Still, what the lead researchers at Bastyr University (a naturopathic medical school just north of Seattle) found was that on some measures the kids on placebo did better than the kids on St. John's Wort. Overall, there was no advantage to using St. John's Wort, not that I've been hearing a hew-and-cry in American culture to treat ADHD in kids with herbs.
One interesting bit: the last two listed authors on the study are Joe Biederman of Harvard, who has of course been in the news lately and is the godfather of the alleged bipolar child paradigm, and Jon (Jack) McClellan of the University of Washington, who is the chief critic in child psych circles of the alleged bipolar child paradigm. At least they were on opposite coasts for the study.
An odd piece on ABC's "Good Morning America" yesterday wherein the GMA team talked about the worsening American economy, the stress it places on people and the links to depression and anxiety (well understood links, of course). I was half-waiting for them to recommend Prozac when reading the upcoming GDP report, but then GMA pointed out that during the Great Depression of the 1930s the suicide rate in America jumped from 14 deaths per 100,000 people to 17 deaths per 100,000. (BTW, our current rate bounces between 10.5 and 11 per 100,000.)
While it's obvious that economic hard times place enormous stress on people, I think it's a bit odd to emphasize suicides--after all, aren't depression and anxiety enough to get their point across?--especially since I don't think those are the most solid numbers in the world. It wasn't until well into the 1950s that the CDC was able to assemble a comprehensive, nationwide system on reporting fatalities, so that makes me a bit suspicious of the 1930s data. What's more I've looked at enough localized suicide stats over the years to not be entirely convinced that suicides go up during economic dips. If anything, I've seen inconsistent patterns.
That said, let's assume GMA is right about Depression means depression means suicide. What would they suggest we do about it as a culture? Prozac in the water supply? Please.
Anyway, I found the whole thing a bit odd. You can watch it here by following this link. Sorry I couldn't score an embedded version.
Via Newsbusters.org.
AstraZeneca today submitted its atypical antipsychotic Seroquel XR to the European Union for approval as a maintenance treatment for major depression. This follows recent US submittals to the FDA of the same drug for three separate depression indications. The company plans to submit the drug later this year to the EU for approval for generalized anxiety disorder.
I'm still waiting to see AZ publish its data on Seroquel's performance in treating depression and anxiety.
Much credit to AHRP and Pharmalot for picking up an interesting bit on one the defenders of Harvard child psychiatrist Joe Biederman who was touted in Sunday's New York Times piece as "a true visionary in recognizing this illness in children [bipolar disorder], and he’s not only saved many lives but restored hope to thousands of families across the country." The person defending him was Susan Resko, head of the Child and Adolescent Bipolar Foundation. Biederman sits at the head of CABF's advisory council, a conflict that was not caught by the Times. One of CABF's major funders is Janssen (a J&J subsidiary), which makes Risperdal, an atypical antipsychotic that was approved last year for use in kids 10 and above with bipolar disorder.
Biederman is in the news for failing to disclose, along with two other colleagues, oodles of money the group received from pharma companies to research their drugs.
Also on CABF's advisory board are Janet Wozniak, a colleague of Biederman's at Harvard, and Melissa DelBello, a psychiatrist at the University of Cincinnati, who was previously criticized by Sen. Charles Grassley for monies she got for AstraZeneca.
Ah, what webs we weave.
Some more contributions came in yesterday bring the fundraiser total to $2,066, or about $536 shy (counting a couple of pledged amounts) of the $2,500 goal by the end of tomorrow. So it's close to the goal and I'd just ask those of you who haven't contributed already to please go to the PayPal button on the right and contribute what you can to keep this site blazing through the summer. Assuming summer ever comes to Seattle this year.
If you prefer using snail mail, shoot me an email and I'll send you a mailing address.
Thanks for your support.
The blogosphere was all over this weekend's news that three Harvard child psychiatrists had wildly underreported their payouts from Big Pharma. CL Psych took it on, so did Pharmalot, so did Psych Central, so did the WSJ Health Blog, so did Soulful Sepulcher and so, most strikingly, did the Carlat Psychiatry Blog, authored by Danny Carlat, a clinical professor of psychiatry at Tufts who received his training at Harvard.
Carlat argues that too much shouldn't be made of the payouts and, indeed, yesterday I pointed out that the whole thing might be tied to accounting issues (I've seen this in research funding before). Here's Carlat's argument:
"I am inclined to give them the benefit of the doubt on this issue. I don’t think they hid these payments out of greed, sneakiness, or the thrill of getting away with something. They probably simply didn’t believe these earnings were relevant to the NIH funding they received. If you look at the charts detailing each doctor’s income in the Congressional Record, you can get a sense of why this might have occurred. Many of the large payments were not from drug companies directly but from third party medical education companies, with vague and uninformative names such as 'Phase 5,' 'MedLearning,' 'Strategic Implications,' and 'Primedia.'"
This has led to a big debate on his blog, as you can imagine. While this may all be a plausible explanation, I'm not in a mood to be charitable to the Harvard 3--they are responsible for doping up tons of American kiddos and should be held accountable, especially if they've violated NIH rules.
To me, this whole mess calls into question the research used to support the bipolar child paradigm--how solid is their data? how legitimate are their measures of drug-induced benefits? who's going to look into it?--and makes it very clear that we need a sea change in this country in how research is funded and how doctors go about revealing their funding to the public. The system stinks and it's time to de-stinkify it.
Let' it rip in comments, readers.
Last night, Ken Griffey, Jr., a right fielder with the Cincinnati Reds and a former star center fielder with the Seattle Mariners hit his 600th home run in the Majors. Although it's not getting much fanfare, the feat puts him in rarefied company: Aaron, Mays and Ruth (Bonds and Sosa also have 600-plus homers but they were steroid cheaters and are dead to me). Griffey never cheated with performance enhancing drugs or corked bats a la Sosa.
What hasn't shown up at all in the press accounts of The Kid's career, which have been coming out the last few days, is that when he was 17 years old, he tried to kill himself and somehow cheated death.
Think I am joking. Here it is in this 1992 article in the Seattle Times.
"In January 1988, Junior swallowed 277 aspirin, by his own count, and wound up in intensive care in Providence Hospital in Mount Airy, Ohio. He thought about killing himself a couple of times, he said, 'with my father's gun or something.'"'The aspirin thing was the only time I acted,' he said. 'It was such a dumb thing.'
"The story emerged during a recent wide-ranging interview, in which Griffey spoke about some of the ups and downs of his teenage years. He agreed to make it public in the hope it might dissuade someone else from seeing suicide as a solution.
"'Don't ever try to commit suicide,' Griffey said he wants to tell kids. 'I am living proof how stupid it is.'"
It's not clear to me when Junior will retire--maybe this year, maybe next--but he will surely go into the Hall of Fame on the first ballot five years after he does retire. His suicide attempt happened a year before he took his first AB in the Big Leagues, the result of some kind of panic and psychic pain he was in is my nearest guess. So, in a way, he'd already won a very large fight before he ever faced down a 98 MPH fastball. And, 20 years later he'll remain one of the biggest symbols against the empty solution of suicide.
For those of you who want to dork out on his career stats, go here. The amazing thing--and the sad thing--is that Junior has missed about three-and-one-half years of games due to various injuries over the years and he could just as easily have topped 700 homers. Somehow, I bet he doesn't care.
Here's one of his many classic Nike commercials from the 1990s. All the background scenes are in Seattle.
Shire has had many problems with the Daytrana patch. An earlier recall was because they couldn't get it to stay on peoples' skin. Now this:
"Shire Ltd. said Monday it is voluntarily recalling some of its Daytrana attention deficit hyperactivity disorder skin patches because some people could have difficulty removing the release liner, or backing material, of the patch before applying it to the skin."
Not such a big deal, but when you are marketing a drug for kids and adults with ADHD, then you'd better make it easy to use. One wonders why they don't just copy the Nicoderm patch.
Another $60 came in over the weekend. Combined with already pledged amounts, this brings the total for the fundraiser to $1,900. The overall goal is $2,500 by the end of Wednesday. So that leaves $600 with three days left.
As usual the PayPal button is on the right. If you prefer snail mail, send me an email and I'll shoot you a mailing address.
I appreciate all of your contributions to date and look forward to winding up this fundraiser over the next few days.
I'd planned on more than just the posting on the Harvard child psychiatrists for today, but sadly I am down with a fairly aggressive cold-flu thing that's been bouncing around Seattle, so I may have to leave it at that for today. Unless I rally after getting a good, hard sleep.
Some of you are aware that yesterday the New York Times had a front page article detailing multi million dollar payouts from pharmaceutical companies to Joe Biederman, Timothy Wilens and another Harvard/Massachusetts General psychiatrist. These researchers are the chief proponents of the bipolar child paradigm and the leading researchers of ADHD in children. Their influence on child psychiatry in the US and elsewhere has been vast over the past 15 years and has resulted in millions of children being diagnosed with mental disorders and placed on aggressive medication protocols, a social experiment without parallel in American history. This is the same group of researchers who last week declared that teens who smoke and drink should be screened for bipolar disorder.
Vast too has been the amount of money they've been paid by pharma companies, which they have apparently underreported to both Harvard and a Senate committee looking into all manner of tangled relationships between pharmaceutical companies and academic researchers. They may well have violated university reporting requirements and NIH research regulations, according to the Times, and that could place future research grants at risk for the university. The paper also indicates that the university and NIH are investigating the researchers.
What's stunning to me is just how much money these researchers were pulling in.
Biederman: $1.6 million from 2000 to 2007
Wilens: $1.6 million from 2000 to 2007
Thomas Spencer: $1 million from 2000 to 2007.
The paper notes that these figures may understate how much these researchers pulled in from Big Pharma because, in some cases, the companies reported to the Senate committee that they'd actually paid them more.
"In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found."The Harvard group’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.
"In an e-mailed statement, Dr. Biederman said, 'My interests are solely in the advancement of medical treatment through rigorous and objective study,'and he said he took conflict-of-interest policies 'very seriously.' Drs. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules."
It's entirely possible that they have complied with conflict rules because of how complex all of the various accounting systems are. But one has to wonder why they were so wildly understating their earnings and what should be done about this sort of thing. Sen. Chuck Grassley (R-Iowa) has his own thoughts:
"Mr. Grassley said these discrepancies demonstrated profound flaws in the oversight of researchers’ financial conflicts and the need for a national registry. But the disclosures may also cloud the work of one of the most prominent group of child psychiatrists in the world."
No matter what the outcome, this is a huge blow against Biederman who has done much to popularize the alleged child bipolar disorder among fellow psychiatrists. Since I first started challenging the disorder in November 2006, I've been criticized by defenders of the disorder for being, in effect, a mental illness denier. In truth, I've never questioned that these kids who wind up being diagnosed with child bipolar disorder are distressed and that something untoward is going on. But distress doesn't prove bipolar disorder, which classically requires the presence of manic features. From the Times, we learn how some kids were being classed as having manic episodes:
"The group published the results of a string of drug trials from 2001 to 2006, but the studies were so small and loosely designed that they were largely inconclusive, experts say. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale — well below the 50 percent change that most researchers now use as the standard."
That's simply outrageous and one has to wonder what Biederman's motivation was to upend mania measures to make a drug look good when it wasn't. Even Fuller Torrey, an infamous psych researcher himself, recognizes that this puts a huge black eye on the field of psychiatry:
"'The price we pay for these kinds of revelations is cr