Antipsychotic Use Up 1,000 Percent In Canadian Kids

This from the CBC:

"Medical research out of the University of British Columbia suggests the number of children taking medications known as atypical antipsychotics has increased tenfold over the past decade, CBC News has learned.

"The drugs — a class of medicines used to treat psychosis and other mental and emotional conditions — can have potentially serious side-effects, and are linked to increases in stroke and sudden death in adults.

"Health Canada has not approved atypical antipsychotics for children."

It's all so discouraging that I literally don't know what to say, except to note that it isn't good.

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More Seniors With Mental Illness Than Dementia In US Nursing Homes

I don't know whether to be discouraged by the following news (passed along by an eagle-eyed reader) or to consider it a trend that's to the good yet filled with all kinds of tricky implications, but a study out this week in Psychiatric Services asserts that there are more people in nursing homes due to mental illness--depression in particular--than there are for dementia. What's more, the number of people in nursing homes with mental illnesses grew quite a bit.

"The number of individuals admitted with mental illness increased from 168,721 in 1999 to 187,478 in 2005. The 2005 number is more than 50% higher than the number admitted with dementia only (118,290 in 2005). The increase was driven by growth in admissions of persons with depression—from 128,566 to 154,262 in 2005. Persons admitted with depression had higher rates of comorbid conditions than those admitted with dementia or with neither dementia nor mental illness. They also had high rates of antidepressant treatment and high rates of receipt of training in skills required to return to the community."

An accompanying analysis gives some detail on the age groups involved.

"The NNHS produced the most valid national-level estimates of residents with a mental illness—nearly 102,000 with a primary diagnosis in 2004 (6.8% of residents), of which about 23,000 were under age 65 and 79,000 were aged 65 and older."

For the last few years I've heard from nurses who work at nursing homes in the Pacific Northwest that there are loads of elderly people with depression, bipolar disorder and schizophrenia in nursing homes, pretty much as a replacement for the old state hospital model. What it's like elsewhere in the US isn't clear. I'm not saying that this new study establishes that we are warehousing seniors with mental illness in this country, but it sure does make me wonder what's going on here and what the implications are. (Maybe some Seroquel and Zyprexa.)

Thoughts?

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No Charges Against Psychiatrist In Rebecca Riley Case

A grand jury in Massachusetts has not returned a criminal indictment against Kayoko Kifuji, a Tufts Medical Center psychiatrist, in connection with the doctor's role in the death of Rebecca Riley, a 4-year-old girl who was diagnosed with bipolar disorder and ADHD at 2-years-old. The case has gotten a ton of national attention due to the fact that the girl was actually killed in December 2006 by some of the aggressive medication she was on. Meds prescribed to her included Seroquel, Depakote and clonidine.

Her parents have been charged with first-degree murder and are in jail awaiting trial.

A medical malpractice case brought by the girl's estate against Kifuji continues.

I would've been surprised by any criminal charges against the psychiatrist, but the civil case ought to be a tougher go for her.

The back story on the Riley can be found here.

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Chantix, Zyban, Wellbutrin To Get Black Box Warning On Behavior Changes, Suicidality

This should come as no surprise to anyone, but today the FDA announced that it would require a new black box warning on certain smoking-cessation drugs, namely Chantix and Zyban, and would extend the warning to Wellbutrin (Zyban's name as an anti-depressant) and generic versions of Wellbutrin known as buproprion. The warning will notify patients and doctors of the risk of serious changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

"[FDA safety chief] Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

"The FDA’s request for the additional warnings is based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

"The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped."

Chantix has been in the news for much of the last two years for causing severe behavior changes and even suicides in some people taking the drug (my Chantix back catalog is here), all of which served to dramatically reduce sales of the drug despite a huge advertising campaign by its maker, Pfizer. Since it's an anti-depressant and already carries a black box warning on suicidality like all anti-depressant must, Wellbutrin's warning is likely a small change to extant warnings.

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FDA Panel Votes To Ban Percocet, Vicodin

An FDA advisory panel yesterday voted to recommend a ban on the widely-prescribed painkillers Percocet and Vicodin. Percocet (and its kissing cousin Endocet) is actually a combination of Oxycodone, an almost century-old opioid analgesic medication synthesized from opium-derived thebaine, and acetaminophen. Vicodin is a narcotic analgesic product containing hydrocodone, derived from codeine and thebaine, and acetaminophen. The FDA panel was convened to advise the FDA on how to address tens of thousands of cases of liver damage each year connected to patients taking high doses of acetaminophen either in OTC products like Tylenol or in prescription painkillers like Percocet as well as in cold remedies containing acetaminophen.

Reportedly, FDA data showed that the vast majority of acetaminophen poisoning occurred in connection with opioid-acetaminophen and hydrocodone-acetaminophen combination products, likely due to patients treating pain conditions by taking more and more of the pills to fight off pain, but finding their effects reduced over time and then taking even mroe of the pills and winding up undone because of the acetaminophen.

Earlier yesterday, the panel voted to recommend cutting the maximum dose of acetaminophen in Tylenol and Excedrin, but to not limit the number of pills in a bottle, no doubt a big relief to people who go to Costco and buy their acetaminophen in 1,000 pill bottles--all of which may reduce the effect of cutting dosages.

News of a possible ban on Percocet and Vicodin (and similar opioid-acetaminophen combos) would certainly reduce doctor and patient options for treating pain and it makes me wonder why the panel didn't simply recommend dramatically cutting allowable acetaminophen doses. That said, a ban on the two drugs would be a boon to the makers of OxyContin (Oxycodone plus inert binders) and the makers of opioids combined with either aspirin (Percodan) or ibuprofen.

The New York Times cast matters thus:

"[T]he recommendation is likely to come as a shock to many patients, who may be unaware of the dangers of high doses of acetaminophen--even if they know the drugs contain the ingredient.

"Some doctors already avoid prescribing pills that combine acetaminophen with narcotics like oxycodone (found in Percocet) and hydrocodone (in Vicodin).

"'It ties the doctor’s hands when you put the two drugs together,' said Dr. Scott M. Fishman, a professor of anesthesiology at the University of California, Davis, and a former president of the American Academy of Pain Medicine. 'There’s no reason you can’t get the same effect by using them separately.'

"Dr. Fisher said the combinations were prescribed so often for the sake of convenience, but added, 'When you’re using controlled substances, you want to err on the side of safety rather than convenience.'"

"Still, some doctors predicted that the recommendation would put extra burdens on physicians and patients.

"'More people will be suffering from pain,' said Dr. Sean Mackey, chief of pain management at Stanford University Medical School. 'More people will be seeing their doctors more frequently and running up health care costs.'"

The FDA isn't bound by advisory panel recommendations but often goes along with them.

While it's easy to brush this news off as a matter of patients not knowing the dangers of using too much acetaminophen, my own experience with pain pills is that not once in the several times that I've been prescribed Percocet and Vicodin (for bruised ribs and for occasional use for chronic back pain) has a doctor ever warned me about not taking too many pills due to concerns with acetaminophen. Patients aren't the only ones who need a refresher course on acetaminophen.

It's frustrating to me that two pretty decent painkillers might be banned because of ignorant patients and doctors. It will be interesting to see how the FDA handles the panel's recommendations.

Keep in mind that while some Percocet and Vicodin does get diverted into the illicit drug trade, it's really the purer OxyContin that's causing problems there as it can easily be crushed and snorted, creating an effect similar to heroin (or so I'm told). As far as I know, very few people would crush and snort a Percocet as there'd be no way to remove the acetaminophen (as far as I know).

It's ironic to me that an FDA panel is paying this much attention to side effects from pain pills while similar FDA panels routinely ignore serious side effects connected with anti-depressants, antipsychotics, benzodiazapines and other psychotropic drugs. Go figure.

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Why Does Ambien Make People Act Weirdly? A Mice Study Explains

Or should I say tries to explain, since animal studies are usually fairly tentative in their findings and applicability to humans? That said, researchers have been using a mouse model to examine why some people who take Ambien, the well-known sleeping drug, do things like sleepwalking, sleep-driving and other odd-to-them behaviors, often with no memory of the event.

From Reuters:

"Ambien, made by Sanofi-Aventis, can shut down powerful brain circuits responsible for inhibiting brain activity under certain circumstances, leaving other brain circuits unchecked, researchers at Georgetown University Medical Center in Washington said.

"'You are kind of releasing the brakes,' said Molly Huntsman of Georgetown, who worked on the study that appears in the Proceedings of the National Academy of Sciences.

"This may stimulate brain circuits that would normally be silenced. 'In a way, Ambien is awakening other circuits because the brakes are not in place,' Huntsman said.

"To study the effects of the drug, known generically as zolpidem, Huntsman and colleagues conducted a series of experiments in mice.

"The team wanted to see how mice on the drug would respond when the researchers trimmed their whiskers, which rodents use as their primary sensory system -- much like humans rely on vision to take in information about the world.

"The team found that mice that were deprived of this sensory information had changes in their brain that affected the way they responded to the drug Ambien.

"'It's a population of neurons that is normally in place to stop activity. We find what Ambien does is inhibit their function to inhibit,' Huntsman said in a telephone interview."

I wasn't able to pull up the paper from PNAS, but that Ambien may be blocking inhibitions in humans sure would explain a lot of the weirdness that's cropped up around the use of the drug such as this recent tale of a man cheating on his wife one night while on the drug or this sad story from earlier this year wherein a man sleepwalked on a bitterly cold night and died.

It would be interesting to see this mice research replicated in humans.

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FDA Panel Calls For Tylenol, Acetaminophen Strength Reductions

An FDA panel meeting to come up with recommendations to address tens of thousands of overdoses each year of acetaminophen--ie, Tylenol, Excedrin, your favorite private label brand, etc.--voted today to recommend to the full FDA that the strength of OTC acetaminophen be reduced. The FDA is not bound by their recommendations.

The AP sketches out the problems around the painkiller and the votes:

"But despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.

"FDA's experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.

"The group was not asked to recommend an alternative maximum daily dose.

"The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Extra Strength Tylenol is 1,000 milligrams, or two tablets.

"In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription."

Not to throw too much cold water on these proposals--it's obvious we have rather large problems with acetaminophen in our culture--I'm not sure that there would be much benefit to the FDA adopting these recommendations, aside from looking like it's doing something proactive. If you lower the dose of acetaminophen by roughly 50 percent, then it's not difficult to imagine that patients will simply up the dose they take, buy more bottles of Tylenol at the store and so on, in order to get the same effect. The opportunities for unintended consequences abound, in my opinion.

Why not simply recommend a black box warning for all OTC acetaminophen warning of liver damage through overdosage, etc.?

It's worth noting that the makers of Tylenol have been running commercials in recent months advising patients to be good to their livers by not taking too much Tylenol.

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Benzodiazepine Use Up Dramatically, Drugs' Addictive Properties Criticized

I know so many people with various mental disorder diagnoses who have taken a benzodiazepine in addition to whatever other medication they were on (and often they were getting a benzo for side effects of, say, anti-depressants) over the years and I've seen many of these people run into very severe withdrawal and addiction problems as a result. The usual suspects are Klonopin, Xanax, and Ativan (there are others of course). Sales of Xanax last year hit $350 million, up almost 50 percent since 2003 and 85 million prescriptions were filled for the top 20 benzos in 2008, an increase of 10 million scrips over 2004, according to this article on anti-anxiety drugs and their problems in today's Washington Post.

Their problems are legendary.

"The ordeal of withdrawing from benzodiazepines can rival that of kicking a heroin habit, according to some who have had success. Abrupt withdrawal can result in hallucinations, seizures and even death, experts say.

"Last year, after jail officials in Cleveland denied R&B singer Sean Levert's repeated requests for his Xanax, he hallucinated for hours and ultimately died from the effects of withdrawal, according to the coroner's report cited in court records. His widow sued the corrections center and medical staff. The suit is pending."

The article certainly serves as a reminder to me of how commonly these drugs are used--85 million scrips could easily translate into more than 10 million people taking benzos--and how their use has boomed, despite all the bad things doctors know about the drugs, during this very anxious decade.

I've not experienced benzo addiction or withdrawal personally, but I know it's utter hell and I'll try to pay more attention to these issues. I think some docs are prescribing these drugs far too casually and for too long a period of time.

During my 18 years in the mental health system, I was only ever prescribed Ativan at 1 mg. a day to take as need to, drum roll, treat agitation I was experiencing from Seroquel and Lamictal. My then-psychiatrist and I worked out a deal where he would only write me a scrip for 15 pills every two or three months and would only renew the scrip in person instead of over the phone or by fax. He said he wanted to make damn sure I didn't get hooked on the drug and I'm thankful he took that approach, even though I'd been waved away from benzos by other docs and patients for many years at that point.

Ativan was a nice enough drug for me, but then I never took it for more than a day or two at a time.

A friend once gave me a Xanax--I forget which dosage--and it knocked me out so hard that I fell asleep on my usual bus and missed my regular stop by one mile. Not so nice.

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Parents Cope With 6-Year-Old With Schizophrenia

This is one of the most discouraging articles I've read in a while: today the Los Angeles Times reports on the case of a 6-year-old girl in LA who is diagnosed with schizophrenia and her parents' desperate attempts to deal with her, find housing, etc. It's a tough read, especially because by its end we learn that the girl is on a cocktail that includes Thorazine, possibly the worst of the first-generation antipsychotics.

The article is well done and duly notes that schizophrenia among children so young is incredibly rare.

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Doctors On CNN, Fox News Criticize Long-Term Anti-Depressant Use

I was blown away on Saturday when, during cable news coverage of Michael Jackson's death, two doctors offering analysis were very critical of Jackson's reported long-term, chronic use of both painkillers and anti-depressants and noted that they could affect someone's heart health (while that's likely obvious to one and all with painkillers, it's probably not so obvious with anti-depressants). Sadly, I cannot find transcripts of either doctor on Fox News and CNN, but I can assure you they said it and it was a stunner to me, given how the mainstream media ignored the connection between anti-depressant use and sudden cardiac death in women, as reported by researchers in the Nurse's Health Study. It's also a stunner to me in light of how naive we've been as a culture when it comes to using anti-depressants very casually while assuming that there's no long-term impact from using the drugs.

Jackson was allegedly on a staggering cocktail of prescription drugs: thrice daily injections of Demerol; Dilaudid; Viccodine; and 120 mgs. a day of Zoloft and 40 mgs. a day of Paxil. He was supposedly taking the anti-depressants for OCD and social phobia issues. What Jackson was taking at the time of his death isn't entirely clear, since his toxicology report won't be available for many weeks and also since last night his personal physician, Conrad Murray, reportedly told Los Angeles police detectives that he hadn't injected Jackson with Demerol and, in the words of the doctor's lawyer, "There was no Demerol. No OxyContin."

He said nothing about anti-depressants, however.

So we shall see how all this prescription business plays out. Of course, Jackson was known to have used painkillers for many years to treat chronic pain problems and it's entirely possible that he'd become addicted to them. It's entirely possible that Michael was hooked on anti-depressants as well. Certainly, SSRIs can be very addictive (or create physical dependency, if you prefer) for some people.

That said, I want to make it clear that I am not blaming Zoloft and Paxil for Jackson's death. I am not saying that taking either drug will give any specific person a heart attack. But I am saying that, for now, that the two anti-depressants are inextricably entwined and linked to the death of MJ.

The research on long-term anti-depressant use is thin to begin with and there's not a lot of research on links between anti-depressant use and heart problems, but it is obvious to me that there is clearly something going on here and, as I wrote back in March, the nurse's study should be a big wake up call to doctors who've had patients on anti-depressants for many years and for patients themselves.

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Michael Jackson Allegedly On Anti-Depressants, Painkillers

Here we go:

"Life & Style reports that Michael Jackson was taking a cocktail of up to seven prescription drugs in the months before his death.

"And a Jackson family lawyer told CNN he 'feared' the drugs could kill the pop star.

"The star had been taking prescription painkillers including anti-anxiety drugs Xanax, Zoloft and painkiller Demerol in recent months, sources close to Jackson told Life & Style. The insider close to the star said he took a suspected overdose of drugs on Thursday morning, which caused respiratory and cardiac arrest.

"Jackson family lawyer Brian Oxman confirmed Jackson may have had trouble with prescription drugs as he prepared for his London show.

"'This was something which I feared and something which I warned about,' Oxman said on CNN. 'I can tell you for sure that this is something I warned about. Where there is smoke there is fire.'

"Mr Oxman compared Michael to Anna Nicole Smith, alleging that Michael had 'enablers' just like her."

I don't even know what to say, except that there will be much, much more to come on this story.

On a personal level, I am crushed by Michael's death. I grew up on the Jackson 5 and loved "Off The Wall" and "Thriller." Obviously, Michael became a very weird adult, but he sure as hell deserved an opportunity to redeem himself. It's sad that those London concerts will never happen.

That he died of what appears to be sudden cardiac death makes me wonder greatly about what his toxicology results will be.

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A Nice Award, And A Peabody Award Questioned

Last week, PsychCentral.com's John Grohol handed out some journalism awards for writing on mental health issues online, driven by recent media awards from Mental Health America which completely ignored the online world. Freelancers Shannon Brownlee and Jeanne Lenzer won for a Slate.com article on conflicts around "The Infinite Mind" radio show; the New York Times for its "Patients' Voices" series; Danny Carlat won for being Danny Carlat; CL Psych won for being CL Psych; Jeremy Dean at PsyBlog won for writing about limited research behind so-called brain training programs; The Last Psychiatrist won for being The Last Psychiatrist; Vaughan Bell at MindHacks.com won for disemboweling fMRI claims; and, "Like him or hate him (he tends to be polarizing)," yours truly won for thumping out this blog and offering the public court documents and so on.

I certainly appreciate the hat tip, particularly as this year marks the first time since 1999 that I have not won a print journalism award of some kind. That's mostly due to the fact that the freelance market has melted down--a publication I wrote for on occasion told me last week that they have no more freelance money for at least the rest of the year, which is simply stunning--which means I don't get to do much print work these days. Sadly.

More importantly, a PBS documentary "Depression: Out Of The Shadows" recently won a Peabody Award (one of the biggies in TV journalism) as well as recognition from Mental Health America (see above link). But now the Columbia Journalism Review picked up on the fact that the much-discredited Emory University psychiatrist Charles Nemeroff had appeared on the program and made some spurious claims:

"Some might argue that little about this episode matters, since Nemeroff’s downfall took place in October and Depression: Out of the Shadows aired five months earlier. Yet a simple Google search would have alerted McPhee to the fact that Nemeroff, though the author of hundreds of research papers and well respected in his field, has been dogged by conflict of interest allegations for years. In 2003, he came under fire for praising three pharmaceutical products in the journal Nature Neuroscience without disclosing he held a financial stake in their success, one of which he held the patent on...."

"But what made the praise bestowed on this PBS documentary particularly troubling were the erroneous, drug-industry serving statements made by Nemeroff within the film—statements which had the potential to negatively affect public health, and which the documentary left unchallenged. During a segment on the FDA’s 2004 decision to require “black box” safety warnings stating that antidepressants can increase the risk of suicide in children and teenagers, a risk it extended in May of 2007 to users under twenty-five, Nemeroff seized the occasion to claim that the federal safety warning was mistaken."

Oh, yes. The CJR writer questions the validity of the Peabody award in regards to all of that. Personally, I don't have much taste for being a journalist questioning other journalists' awards, so I'll leave it at that. I felt the program was OK-ish and in writing about it last year ignored an appearance by Emory University's conflict of interest king Charles Nemeroff as I was simply exhausted by earlier news about the doc. I was furious about the program's pimping for ECT, however.

For what it's worth, I sure didn't set out to be polarizing when I began this blog almost four years ago and I don't try to be polarizing each day. I realize that that dynamic is out there and that I have that reputation, earned or not, and that it sometimes loses me readers and contributors. The reality is that I have taken a very firm stance that the public--the ones footing the bill for psychiatry and Big Pharma--has an absolute right to know how convoluted the game has become and who is behind the curtain and so on.

As I noted last year when I wrote about responses to my writing on David Foster Wallace's suicide, if no one pushes the intellectual envelope and if no one asks difficult questions, then nothing ever changes. And things have got to change.

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Psychiatrists Attacking Psychiatrists For Blogging On Disclosure Controversies

There are a few bits of news in this post but they are tough to organize: suffice to say that the politics around the forthcoming DSM-V are becoming very intense and nasty and, slightly connected, psychiatrist-bloggers Doug Bremner (Emory University) and Danny Carlat (Tufts University) are drawing the ire of some colleagues for writing honestly about psychiatry's epic conflict-of-interest problems, earning both a marginalization campaign from others in psychiatry. Yes, it is getting ugly out there.

First, Bremner notes an in-press article at Psychiatric Times by Allen Frances, a psychiatrist who chaired the DSM-IV committee, is deeply critical of the deeply secretive DSM-V process and delivers a stern assessment of the process, the kind that might embiggen the heart of an anti-psychiatrist (article obtainable at Bremner's site):

"The work on DSM-5 has, so far, displayed an unhappy combination of soaring ambition and remarkably weak methodology."

Bremner summarizes further:

"[Frances] then goes on to explode the statements by Kupfer that the DSM-5 will lead to a 'paradigm shift' in psychiatry, which he describes as an 'absurd statement' based on the fact that there still is not a single lab test for diagnosis, and the gains are small and incremental in descriptive research. In the absence of evidence, changes in diagnostic criteria are arbitrary and often driven by a single strong member of the sub-committees. Furthermore, the incorporation of sub-threshold diagnoses as official psychiatric diagnoses will be a 'bonanza' for drug companies who will expand their markets to new legions of the 'newly' mentally ill and rush to 'educate' doctors about the new criteria, which they will use to expand drug usage. It will also serve to expand stigma."

I agree with Frances' points. I've made similar points before and, of course, when I've noted the incrementalism of bipolar disorder type 2 and how it created a new, mostly unnecessary market for pharma companies, I've taken a thorough drubbing. So it's nice to see that Frances, by implication, has my back on some of this.

Bremner himself has created a "Shadow DSM Team" to track the new DSM. This seems to have landed him in some hot water with colleagues, as a post he wrote last month on proposed Developmental Trauma Disorder in children mentioned that some involved in developing possible criteria for the disorder came from institutions (Brown, Dartmouth) with huge conflict-of-interest problems. For this Bremner is paying a price:

"I got an email from someone on the DSM Anxiety, OCD, PTSD and Dissociative Disorders committee whom I thought was a 'friend' un-inviting me to be an author on a paper about another topic (that was after I had already spent several days working on the paper)."

There's some nice revenge. What's interesting is that Bremner has always written about Emory's many conflict of interest problems and that seems to have PO'd some at that school who then used a long-ago Bremner post (part serious, part satirical) about my smoking and losing my housing over the same to demand that Bremner disassociate his blog from the fair, driven-snow reputation of Emory. That's how lame it's getting out there in academic psychiatry.

It gets lamer still. Danny Carlat reports on his blog that some folks within the American Psychiatric Association are trying to keep him off a guidelines review committee over a comment someone left on his blog earlier going after Stanford's Alan Schatzberg, who recently became president of the APA. Read his post for the details.

I know that Bremner and Carlat are both disturbed by the academic snubbing from their colleagues and I imagine their surprise is large as well since the two are moderate critics within their field, mostly of conflicts of interest and rampant pharma-funding of continuing education. I say they should wear their shunning as a badge of honor and realize just how deeply out of touch with reality some of their colleagues seem to be.

Perhaps we can come up with a new disorder in DSM-V to describe the condition.

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Pres. Obama Should Push Back On Questions About His Smoking

I've noted before that the DC media has had much fun poking at President Barack Obama about how much he still smokes and how I think the media ought to stay out of the President's private life (or do they plan on asking what he eats each day, if he drinks soda pop and whether he and the First Lady have sex?) and stick to far more important questions.

But, no. During yesterday's press conference a reporter who identified herself as a former smoker went after President Obama about smoking. If I've watched one trend over my 15 years as a reporter, it's that once a media person stops drinking or smoking (or whatever), they become most virulent in attacking that which they once did. For instance, I know of recovering alcoholics in the press corps who will go hammer-and-tong on homeless housing programs where chronic inebriates are allowed to drink, even though there's good evidence that such programs are helpful, simply because the method of stopping drinking that worked for them must work for one and all (no, I won't get into any names here). You'd think their editors would be smart enough and attentive enough to questions of unfair bias to assign such stories to clearer minds, but when it comes to that perceived to be a vice all those old standards fall apart.

Here's yesterday's exchange (deep down in this transcript) between McClatchy's Margaret Talev and President Obama:

"Q: How many cigarettes a day do you now smoke? Do you smoke alone or in the presence of other people? And do you believe the new law would help you to quit? If so, why?"

"THE PRESIDENT: Well, first of all, the new law that was put in place is not about me, it's about the next generation of kids coming up. So I think it's fair, Margaret, to just say that you just think it's neat to ask me about my smoking, as opposed to it being relevant to my new law. (Laughter.) But that's fine, I understand. It's an interesting human -- it's an interesting human interest story.

"But I've said before that, as a former smoker, I constantly struggle with it. Have I fallen off the wagon sometimes? Yes. Am I a daily smoker, a constant smoker? No. I don't do it in front of my kids, I don't do it in front of my family, and I would say that I am 95 percent cured, but there are times where -- (laughter) -- there are times where I mess up. And, I mean, I've said this before. I get this question about once every month or so, and I don't know what to tell you, other than the fact that, like folks who go to AA, once you've gone down this path, then it's something you continually struggle with, which is precisely why the legislation we signed was so important, because what we don't want is kids going down that path in the first place. Okay?"

If the President was once a pack-a-day smoker, then 95 percent cured would translate into something on the order of seven cigarettes a week as his current consumption (rumor has it he smokes Parliament Lights, or P-Funks as they are known), plus all that nicotine gum he reportedly chews--and the media is chipping him up about it? And asking if he smokes in front of others? Does Talev ask stupid, biased questions in front of the world? Please. I'm glad the President called Talev, clearly religious on the matter (hopefully, her bureau chief chewed her ass out afterwards), out for messing with him on what is fundamentally a trivial matter and a personal choice.

That said, I'm a bit tired of watching the President handle the smoking question with such selfishness (I don't know another term to use here, but I can assure you that his smoking is not all about him). The reason the media keeps pressing him on smoking has very little to do with him per se and everything to do with a culture war over smoking and other Nanny State concerns (food, soda pop, weight, exercise, guns, etc.). Between 40 million and 50 million American adults smoke cigarettes regularly and there are millions more closet smokers out there as well. The sheer persistence of this bloc of smokers drives the anti-smoking advocacy groups (funded with billions of dollars from pharma companies, pharma-connected foundations and a huge slush fund from the Master Tobacco settlement of the 1990s) and Nanny State health departments absolutely batty. They've been rolling out their smoking education programs since the early-1990s (often making spurious claims about smoking), running smoking ban initiatives throughout the country (often making unscientific claims about secondhand smoke), driving up the price of cigarettes and other tobacco through their tax-loving minions in various state legislatures and the Congress and, finally, getting regulation of tobacco into the hands of the FDA. And yet 40 million to 50 million adult Americans make the choice each day to light up. (For the record, I am one of them.)

What the anti-smoking advocates want is a big symbolic victory, their grand teaching moment and they want it in the form of President Obama.

I think that the President should use the opportunity to shift the conversation from one of when is he going to quit 100 percent (from the looks of things, I'd say never) to pointing out to his occasional interrogators on the subject that the tens of millions of Americans who do smoke also have rights and that those rights are being trampled on a regular basis. I don't even think I need to get into the housing discrimination that smokers now face across the country and that a lot of that discrimination disproportionately targets lower-income Americans and, in some cases, Americans with mental illnesses such as schizophrenia (some of the most disadvantaged Americans of all). The President ought to use questions about his smoking to point out how nutso this kind of discrimination has gotten (real world example: a friend of mine in Seattle was recently denied a new apartment due to the fact that he told the landlord he wouldn't smoke on the property and the landlord told him that he wouldn't rent to a smoker under any circumstances regardless of where they smoked), particularly in regards to a product that is legal (or are we going to start denying rental housing to someone who drinks a six-pack a week?). It would be really nice to hear the President go all-contrarian and community organizer on the ex-smokers who toy with him.

I think President Obama should use future questions about his smoking to make the point that, like it or not, nicotine is a stimulant, well-known as such for hundreds of years and that it does have beneficial effects (as does caffeine, as do other stimulants). The President could even use these supposed teaching moments for a teaching moment of his own and ask why if so many millions are into nicotine while the most common delivery method of said nicotine is allegedly so bad, then why hasn't some smarty pants come up with a better, safer nicotine delivery method. I can assure you that nicotine gum is not a replacement and neither are the Swedish snus and the e-cigarettes. There is something deeply magical about a cigarette and perhaps it's time for a federal stimulus program to find a way to replicate that magic in a more socially-acceptable form.

In other words, it's time for President Obama to stop acting so conflicted about his own smoking and embrace it a bit more, at least psychologically, and also realize that the game is far bigger than his own smoking and that it speaks to the concerns, in all directions, of many millions of Americans who smoke and are feeling quite put upon these days.

It sure would be a hell of a lot simpler than figuring out what tone to strike on Iran, dealing with the economy or engineering a victory on health care reform.

Posted by Philip Dawdy at 11:45 AM | Comments (13) del.icio.us Digg it reddit

Sen. Grassley Goes After Medical Schools To Reveal Pharma Ties Policies

Sen. Charles Grassley (R-Iowa) has struck again, today sending a letter to 23 medical schools and asking them to reveal policies on conflicts of interest and requirements for disclosure of financial relationships between faculty and Big Pharma. The 23 schools had previously not responded to a similar request from the American Medical Student Association.

"'There's a lot of skepticism about financial relationships between doctors and drug companies,' Grassley said in a statement. 'Disclosure of those ties would help to build confidence that there's nothing to hide.'"

Schools on the list include Tulane University School of Medicine, Dartmouth Medical School, Howard University College of Medicine, Louisiana State University School of Medicine - New Orleans, New York College of Osteopathic Medicine of the New York Institute of Technology, University at Buffalo School of Medicine and the University of South Carolina School of Medicine.

It ought to be fun to see what kinds of responses the Senator gets.

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Slow, Slow News Week

It happens each year and usually in June, and so far this week I've seen very little news on interest or import on the mental health front. I doubt that the trend lasts, so I expect to be back to a vaguely regular pace soon, perhaps later today.

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Where Do Psychiatrists Turn With Their Problems? Other Psychiatrists

Elissa Ely, a Massachusetts psychiatrist, has an interesting essay in the New York Times:

"Psychiatry is a relatively safe profession, but it has a hazard that is not apparent at first glance: if you are in it long enough, there may be no one to talk to about your own problems."

As Ely writes there are some psychiatrists who have been psychotic and were able to return to practice--although shouldn't a patient get a full disclosure on that kind of thing?--and it made me wonder what percentage of psych docs have ever been on psych meds. I have no idea.

Anyway, as it turns out, psychiatrists turn to other psychiatrists for help with their own problems. No surprise there. I wish I knew how they felt about the experience.

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Questioning Antipsychotics In Kids, SF Chron Supports Their Use

From time to time, I simply shake my head at the quality of health journalism in the US, particularly as regards children's mental health. Today's example comes to us from the San Francisco Chronicle in an article entitled "Antipsychotic drugs for kids raise hope, worry." While the article does get at both the hope and worry around the use of these drugs in kids, it remains uncomfortably biased toward promoting the use of antipsychotics in kids to the point where you've got to wonder who the reporter's sources were and who the hell is editing at the Chron these days.

The trouble starts in the lede:

"Increasingly powerful antipsychotic drugs available on the market, and growing evidence that starting these medications early can help children with conditions like bipolar disorder, is putting doctors under more pressure than ever to diagnose and treat young people with mental illnesses.

"As a result, some doctors say, mental illness, especially bipolar disorder, has been overdiagnosed much the same way attention deficit hyperactivity disorder was in the 1980s."

OK, how would the availability of a drug put docs under pressure to diagnose and treat people? What growing evidence that starting these medications early helps children with alleged bipolar disorder? Certainly, the article offers no evidence and, to date, there's no long term "evidence" to support the use of these drugs in kids and the shorter-term studies aren't particularly conclusive either. But there it is in black and white and you've got wonder if there's a skeptical eye at the paper at all, especially when we're talking about a diagnosis--pediatric bipolar disorder--that is deeply controversial within child psychiatry itself when applied to kids younger than 12 or so.

And the antipsychotics are "increasingly powerful?" Compared to what? Older antipsychotics? Really? That's a statement that makes no sense.

The article does a decent job of talking about of overdiagnosis of bipolar disorder in kids and teens and fleshes out some docs' concerns about misdiagnosis, but at core the paper completely accepts the validity of the disorder in children and then sets about quoting a NAMI official:

"Dale Milfay, vice president of the National Alliance on Mental Illness in San Francisco, said it's crucial that children with mental illness get a correct diagnosis as soon as possible and start treatment right away. There may be medical advantages to early treatment, she said, but children also benefit from staying in school and developing crucial relationships with friends and family.

"'The earlier people are diagnosed, the better their chances,' Milfay said. "'But you wouldn't want these drugs to be overused. There needs to be some real criteria that this is not something a primary care doctor can just diagnose.'"

While I appreciate someone from pharma-funded NAMI striking a cautionary note, I'd really love knowing where their evidence is of early diagnosis being crucial to child development, especially when you have some experts in child psychiatry who claim that kids who get hit with bipolar diagnoses as kids don't wind up having bipolar disorder as adults.

Like I said above, I sure do wonder about the state of health care journalism these days and my concern isn't idle given that health care comprises about 25 percent of the American economy these days.

Posted by Philip Dawdy at 12:03 AM | Comments (13) del.icio.us Digg it reddit

FDA Pulls Sexual Stimulant Pill Finding It Contains Unapproved Erectile Dysfunction Drug

That headline is not a joke:

"FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all products sold under the name Stamina-Rx. FDA lab analysis found that the product contained the undeclared ingredient − benzamidenafil − a drug in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction. Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product. Stamina-Rx is sold predominantly in health food and drug stores nationwide. Consumers who have this product in their possession should stop using it immediately."

I wouldn't even know where to begin with wondering how such an unlicensed compound would get into an over-the-counter pill. Man, is the company ever going to have some PO'd customers.

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House Version Of Health Care Reform Out Now, Includes 8 Percent Payroll Tax

Via the New York Times's The Caucus blog, comes news that the House version of health care reform has been released. There's a link on that blog to the very large pdf of the proposed legislation, which would of course have to be reconciled with any Senate bill.

The Times notes:

"The House proposal unveiled on Friday was a decidedly progressive measure, which reflected many of the ideas championed by the White House, including such initiatives as the creation of public insurance plan, which Republicans have said they will never support.

"In the Senate, lawmakers have been working on a number of potential compromise proposals, including the creation of nonprofit health care cooperatives that could compete with private insurers but would be regulated rather than controlled by the federal government.

"The House proposal also included a requirement that employers either provide health insurance or pay a fee equal to 8 percent of their payroll. The House chairmen said that the 8 percent figure, along with virtually every other aspect of the draft legislation, was negotiable and intended as a starting point for deliberations.

"But Republicans have voiced opposition to imposing any such requirement on employers, arguing that it would effectively lead to the elimination of jobs."

While the 8 percent figure may represent one approach to keeping businesses from dumping their employees onto the public option in the plan, I need to know a lot more about how all of this will work. Funding programs by imposing a new payroll tax on businesses during a deep recession may not be a great idea. I remain to be convinced at any rate.

Posted by Philip Dawdy at 01:14 PM | Comments (0) del.icio.us Digg it reddit

FDA Staff Urge Review Of Developmental Delay, Autism Linked To Depakote

In news just out this morning, FDA scientific staff urge the agency to undertake further review of the anti-seizure drug Depakote, commonly used for various seizure disorders as well as a so-called mood stabilizer in bipolar disorder, due to possible links to cases of developmental delay and autism in children of mothers taking the drug while pregnant. Depakote, made by Abbott Labs, is also known as divalproex in generic form.

"Six cases received since its approval in 1983, including two siblings reported to have autism, 'raise concerns,' Food and Drug Administration staff wrote in a May 6 memo released on Friday.

"Limitations in the reports 'make it impossible to definitively conclude' the drug played a role, and genetics or other factors may have contributed, especially in the two sibling cases of autism, the FDA reviewers said.

"'Further study is needed to further elucidate causality and degree of risk of fetal exposure to (Depakote) and subsequent developmental delay in children,' they added."

In April, a study found that Depakote use during pregnancy led to significantly lower IQ scores in offspring. Last year, a British study reported a sevenfold increase in the risk of developing autism in the offspring of mothers who took Depakote in utero.

Depakote has also been linked to ovarian cysts.

Posted by Philip Dawdy at 11:15 AM | Comments (0) del.icio.us Digg it reddit

AstraZeneca Can't Exclude Diabetes Expert Witness From Seroquel Trials

As I noted yesterday, a few plaintiffs' cases against AstraZeneca over accusations that its antipsychotic Seroquel caused diabetes have been dismissed in Delaware Superior Court recently partly due to a judge's finding that one expert witness could not establish a link between the drug and diabetes. It sure made one wonder where the many thousands of other Seroquel cases were headed.

Now a judge in US District Court in Florida, where about 6,000 Seroquel cases currently reside, has ruled that AZ cannot exclude the testimony of a separate plaintiffs expert witness who will argue a link between the drug and diabetes in some patients. Donna Arnett, professor and chairwoman of the epidemiology department at the University of Alabama at Birmingham, argues that Seroquel causes metabolic changes, which can lead to diabetes.

The ruling affects only cases in federal court.

According to Bloomberg, Tony Jewell, an AZ spokesman, said in an emailed statement:

"'The heart of these cases are unproven claims that Seroquel causes diabetes in individual patients.'

"'Judges at both the federal and state levels have dismissed the initial cases prepared for trial, concluding that plaintiffs did not have sufficient evidence to establish that Seroquel was responsible for their alleged injuries,' he said. 'In the cases prepared for trial to date, plaintiffs have been repeatedly unable to prove their claims in court.'"

Yes, but none of those cases have gone to trial to date or been heard by a jury. It's beginning to look as though at least some cases will go to trial, unless AZ's lawyers have further rabbits to pull out of the hat.

In an Arnett deposition released earlier this year, she called Seroquel unsafe, said it led to an increased risk of diabetes and that it hadn't helped the majority of patients in clinical trials as the majority of patients in clinical trials for the drug had dropped out of the trials.

It will indeed be interesting to see how all of this plays out.

Posted by Philip Dawdy at 10:30 AM | Comments (5) del.icio.us Digg it reddit

WSJ/NBC Poll: Support Soft For Health Care Reform Details

A new Wall Street Journal/NBC News poll came out yesterday, allegedly gauging all sorts of things abotu what Americans think about President Barack Obama and his policies to date. The results aren't especially encouraing for the President's attempts to reform health care, even more so because the poll was completed days before discouraging new details came out about how many people health care reform would actually cover.

"On health care, the public remains open to persuasion. Without being told anything specific about the Obama plan in the survey, about a third of people said it's a good idea, about a third said it's a bad idea and the rest had no opinion. When given several details of his approach, 55% said they favored it, versus 35% who were opposed.

"There was also support for the Democratic push to let people sign up for a public health-care plan that would compete with private companies, one of the toughest issues in the health-care debate. Three in four people said a public plan is extremely or quite important. But when told the arguments for and against the plan, a smaller portion, 47%, agreed with arguments in support of the plan, with 42% agreeing with the arguments against it.

"At the same time, nearly half the participants said it was very or somewhat likely that their employer would drop private coverage if a public plan were available.

"As for how to pay for the package, estimated at more than $1 trillion over 10 years, the public favors proposals to require all Americans to get insurance, to raise taxes on the rich and, to a lesser extent, to require all but the smallest businesses to offer insurance or pay into a fund.

"But majorities oppose plans to tax health benefits, even if the taxes only apply to particularly generous plans. The public is divided about cuts to Medicare."

Extract from all of that what you will.

My own view is that support for health care reform wanes once people learn the details and that does not bode well for broad public support for the "plan"--whatever that plan might actually be. The other thing worth reemphasizing is that this poll was finished two day before the Congressional Budget Office reported that the Senate's Kennedy-Dodd plan, considered the main Obama-backed health plan, would only provide coverage to another 16 million Americans at a cost of $100 billion a year, leaving another 30-plus million Americans without insurance. It will be interesting to see how health care reform pans out in future polls.

It's also deeply troubling that about half of respondents said their employer would cut their health coverage and kick them onto the public plan, if such a plan passed. That would create a budgetary catastrophe. As I've noted before, it is essential that President Obama address this kind of possibility in some fashion, especially if he wants to beat back conservatives who claim he's trying to engineer a government takeover of health care.

Anyway, let's look at an example of how the plan pencils out. At $100 billion a year for 16 million people, that works out to $6,250 a year in insurance cost for each newly covered person or $520.83 a month. Not to be too much of a skeptic, but that strikes me as a very costly plan per person. Right now, I can go out and purchase health insurance coverage for myself through Group Health Cooperative (the big HMO in Washington State) for about $225 a month. The deductible stinks of course, but that's well under half the cost of the Senate plan (according to the CBO's number crunchers) and so this makes me wonder what gives exactly.

Interestingly, a few years ago I know that the COBRA payment for King County (Seattle area) employees was a little over $500 a month for one person and that the coverage was gold-plated: small co-pays for office visits and prescriptions and pretty much everything else covered to a great extent. I'm not saying the proposed Kennedy-Dodd plan is the same thing, but that dollar amount sure does make me wonder.

I'd like to see health care reform pan out (hell, I've been uninsured for two years), but it's beginning to sound, absent a miracle, as if the plan is DOA.

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