Saturday, October 18, 2008

News Flash: This Just In: Breaking News...

Welcome to the 6 o'clock news, I'm your anchor, Woodrow Butdonthaveapaddle. This just in...

Jaak Panksepp, a researcher at Bowling Green State University in Ohio (1), say's he has discovered that rats respond to tickling with actual laughter.

Upon hearing these findings, university officials took away the researcher's pot and told him to stop being such a crazy jagoff.

Thursday, October 16, 2008

It's Not Bipolar

Here is a story sure to delight all those who read it (1). It's about a teacher named Suzy Bass. The beginning of the article summarizes what you'll read about, "This popular teacher told students and friends she was going to die. What no one knew: She'd feigned chemo nausea, shaved her own head and was never actually sick at all." This is called Munchausen syndrome (also known as Factitious Disorder in the DSM-IV).

Here are the following diagnostic criteria:

A) The intentional production of physical or psychological signs or symptoms

B) The motivation for the behavior is to assume the sick role

C) External incentive for behavior (e.g., economic gain) are absent

There are three subtypes: predominantly psychological signs and symptoms; predominantly physical signs and symptoms; and of course combined psychological and physical signs and symptoms.

The reason I chose to write this post is not to highlight a really cool disorder, but rather, to show how bad mental health treatment really is.

Ms. Bass' story begins when she "told her parents that she'd been having breathing problems and persistent colds. Then one day she broke the news: She'd been diagnosed with non-Hodgkins lymphoma, an often deadly form of blood cancer. 'I went with her to chemo on more than one occasion,' says her father, who recalls sitting in the waiting room and watching Bass sign in and walk back to the treatment area."

Eventually, she was exposed...again, "Staffers from a school in Dallas, Georgia--where Bass once taught--had contacted him (the principal of her most recent employer) to expose what they claimed was Bass's latest deception. An employee googled her former colleague to see what had become of her; she found the Knoxville News Sentinel article about the prom fund-raiser (which was in her honor). Bass, the callers warned Hutchinson, had pretended to be a cancer patient during her tenure at their school--and at yet another one in Alabama."

People with this disorder not only go to great lengths to produce signs and symptoms, but they also go to great lengths to conceal the their deception, especially when exposed as frauds, "A week after getting exposed, Bass pulled down her Facebook account, changed her phone number and disappeared."

It is also common to move from location to another, thus allowing them to continue with their charade, "She was at Paulding County for about a year and a half when the Basses got a call that their daughter had passed out at school. A few weeks later, Bass called with a worrisome update: A mammogram had detected a tumor. Soon after, she announced that it was stage II ductal carcinoma."

Her parents even commented that, "she looked sick and appeared to have radiation burns under her arms." Once she was exposed again, the cycle repeated itself, "This time she told her parents that enemies at Tanner High had tried to sabotage her career and that she indeed had breast cancer, it had just gone into remission. A little more than a year later, Bass left for Knoxville."

Bass also exhibited another core characteristic of Munchausen syndrome called pseudologia fantastica (another cool name). This is the fancy term for pathological lying, people who lie for no apparent or rational reason, "Bass acknowledges that there were other lies she'd told friends and colleagues. She once pretended she had a fiancé who died on 9/11, that she'd played basketball at Florida State University and that she'd starred in the North American tour of Mamma Mia!"

Here is the part where it gets disturbing, "Once she left Knoxville, Bass admitted herself into an Alabama psychiatric ward and she told doctors she no longer wanted to live. There, she was diagnosed with bipolar, anxiety and obsessive-compulsive disorders." I know what you're thinking, she didn't tell the doctors about faking cancer. Actually, she did, "currently Bass's counselors have not diagnosed her with Munchausen syndrome and say they are primarily focused on treating her bipolar disorder, but add that her diagnostic review is not yet complete." They know her history, yet they truly believe that she has three serious psychiatric disorders. And they are treating her when the diagnostic review is not complete.

Here is the length this woman went to fake cancer, "she'd shaved her head...she was telling people the end was near..." Moreoever, "Bass had forged a doctor's name on a certificate of disability that she gave Paulding's associate superintendent" and "after spending hours researching cancer on the Internet, Bass learned to draw convincing-looking radiation dots on her neck with a permanent marker (doctors tattoo patients so they know where to line up the radiation machine every day). She would also roll up a bath towel, stretch it between her hands and rub it back and forth against her neck as fast as she could to give herself 'radiation burns.' She shaved her own head with a razor and made herself throw up from chemotherapy 'nausea' in school bathrooms. And all those times her father accompanied her to chemo treatments? After walking through the waiting room door, Bass would meet up with an actual cancer patient--a friend she met at church--and keep her company during her chemotherapy." Her doctors supposedly know all of this, yet they are concerned with treating her bipolar disorder.

Here is what her primary care provider said, "It is certainly possible that given her diagnosis of bipolar disorder, Suzy could have truly believed she had cancer, says Marvin Kalachman, a licensed physician assistant who has treated patients for more than 30 years. He prescribes and monitors Bass's medication under the supervision of a medical doctor." WTF!? Okay I have to break that down part by part.

"given her diagnosis of bipolar disorder." He is assuming that the diagnosis is legit. Cancer can actually be tested for, bipolar disorder can't. Yet, he's certain about her diagnosis. Refer again to the diagnostic criteria for Factitious disorder, "The intentional production of physical or psychological signs or symptoms." You see, psychological signs and symptoms are faked too. Would it not cross you're mind to consider that she might be faking bipolar disorder. No where in this entire article is it mentioned that she experiences manic symptoms. The woman who wrote this article (someone who actually has cancer) said this, "Speaking with a thick Southern accent, she sounded calm and polite, even funny. I could see why so many people had adored her. When she told me about a recent session with her mental health counselor, she joked, 'They charge $90 for 20 minutes and I'm the crazy one?'" Clearly this chick is not depressed either.

"...says Marvin Kalachman, a licensed physician assistant who has treated patients for more than 30 years." Her primary is not even a doctor. Who cares if he's treated patients for 30 years. If they're not psychiatric patients, that means nothing.

"He prescribes and monitors Bass's medication under the supervision of a medical doctor." Okay, unless that medical doctor is a psychiatrist, these two have no business treating this woman. None. Nada. Zip.

However, not all hope is lost. There are some people who are actually trained in this stuff, "Marc Feldman, M.D., a world-renowned psychiatrist, has treated more than 100 women who have faked serious illness. Though he has never met Bass, he believes he has her diagnosis: Munchausen syndrome, a psychological disorder in which someone feigns or self-induces illness to get attention and sympathy." This is someone who should be treating Ms. Bass, not Tweedledee and Tweedledum.

At present, "Bass is currently unemployed, a medical recommendation. 'My counselors don't even want me saying Welcome to Wal-Mart. Here's your buggy,'  she says with a laugh. Bass hopes, though, that her determination will propel her through treatment to a more healthy, happy life. 'I'm working to get past the guilt I feel and move past the mistakes I've made. I'm sick and I'm working on it every day,' she says. 'And I can assure you of one thing. If I can at all control this, it will never happen again." Too late, it already has.

Wednesday, October 15, 2008

Smokers Hate Their Children

Over at my favorite hub for science news, good and bad, I came across this article (1) titled, "Parental Warning: Second-hand Smoke May Trigger Nicotine Dependence Symptoms In Kids." Say it's ain't so. That means I'll have to return my tickets for the 76th annual Blow Smoke in a Baby's Face county fair. The article is in reference to this published study (2), which supposedly found that "increased exposure to second-hand smoke, both in cars and homes, was associated with an increased likelihood of children reporting nicotine dependence symptoms, even though these children had never smoked." So of course, results like these call for immediate action, such as the empowering of local governments to exercise control over the behavior of citizens, "these findings support the need for public health interventions that promote non-smoking in the presence of children, and uphold policies to restrict smoking in vehicles when children are present" [my emphasis].

So give it to me guys, how many of these poor 10 year olds have been gripped by the evil hands of nicotine dependence? "Our study found that 5 percent of children who had never smoked a cigarette, but who were exposed to secondhand smoke in cars or their homes, reported symptoms of nicotine dependence." That's it? A measly 5%? (The study actually states 4.6%). Please tell me that the measures of nicotine dependence are fairly rigorous and that these kids have at least something similar subsyndromal nicotine dependence.

"Classroom administered self-report questionnaires" were completed by these obviously bright 10 year olds. What makes these kids bright? Well here are the 7 nicotine dependence questions that they were asked: (i) How often do you have cravings to smoke cigarettes?; (ii) how physically addicted to smoking cigarettes are you?; (iii) how mentally addicted to smoking cigarettes are you?; (iv) how often have you felt like you really need a cigarette?; (v) do you find it difficult not to smoke in places where it is not allowed?; (vi) when you see other kids your age smoking cigarettes, how easy is it for you not to smoke?; (vii) how true is this statement for you? “I sometimes have strong cravings for cigarettes where it feels like I am in the grip of a force that I cannot control.”

You show me a 10 year old kid who knows the physical and mental symptoms of nicotine dependence, and I'll show a 45 year-old midget named Joey. Seriously, those were the questions. There was no mention of headache, tachycardia, sweating, insomnia, or mood changes. Additionally, these questions were not even validated on 10 year olds. They came from this study (3), which was validated on 14-17 year olds who were actual smokers.

Out of a total of 1,488 kids, only 69 (4.6%) endorsed "at least one symptom of nicotine dependence" [my emphasis]. That breaks down to this: 60% (41) endorsed 1 question, 21% (15) endorsed 2, 11% (8) endorsed 3, 4% (3) endorsed 4, and 2% (2) endorsed 6. Endorsing one symptom means nothing. That's why diagnostic criteria have multiple signs and symptoms. Last night I had trouble falling asleep, which is a symptom of depression, therefore I should seek help, right? It's absurd to make the kinds of extrapolations these people are making. When only 2 kids endorse 6 out of 7 questions, that's hardly an epidemic.

How about the fact that 95% of kids exposed to second-hand smoke (SHS) didn't endorse any symptoms of nicotine dependence? To bad they didn't examine the prevalence of these supposed symptoms in children not exposed to SHS. That would create this thing called a "control group," which would allow people to run fancy statistical tests to determine if the actual prevalence of these symptoms in SHS exposed kids has any actual meaning.

In spite of those limitations, the experimenters said this, "exposure to second-hand smoke among non-smokers may cause symptoms that seem to reflect several nicotine withdrawal symptoms: depressed mood, trouble sleeping, irritability, anxiety, restlessness, trouble concentrating and increased appetite." 'Cough, bull sh*t, cough.'

I don't know if these people actually read the diagnostic criteria, but nicotine dependence is a syndrome characterized primarily by both the development of tolerance and withdrawal (not just cravings alone). None of which are thoroughly addressed by those 7 questions.

In the discussion section, it is said "it is of course possible that participants misinterpreted the questions on nicotine dependence or that either social role modeling or expectations about what participants should experience (rather than what they actually experience) influenced reports of nicotine dependence symptoms. However, we did take susceptibility to initiating smoking and peer smoking into account in this analysis, which presumably took at least some of the effects of social role modeling and expectation into account." Too bad those data are not included in published report. So presumably, it is of course possible that experimenters misinterpreted the data (I can play with semantics too).

They even go on to admit that "there are no 'gold standard' measures of nicotine dependence symptoms in children. Although the items used in this study are psychometrically strong and show content as well as convergent construct validity (That's in adolescents by the way), it is possible that they do not measure nicotine dependence symptoms. Never-smokers could report symptoms they expect by simply smelling cigarette smoke or observing others smoking, rather than those they actually experience. Our measures of SHS exposure were not validated with biomarkers" [my emphasis]. Additionally, since these data are cross-sectional (not longitudinal), cause and effect cannot be determined either.

So what do we have here? A self-report measure of a complex physiological and psychological state that was administered to kids, data that were pooled together so as to appear significant, important data that were omitted from the actual article, and researchers who drew conclusions far beyond the scope of the actual results in an attempt to make their data appear meaningful. If this study were funded by Pfizer, and antidepressants were substituted for tobacco, and depression was substituted for dependence, then we would have something very similar to a typical pharmaceutical sponsored study.

So that begs the questions, who funded this study anyway? These guys did (4), the Canadian Tobacco Control Research Initiative, whose goal is "to catalyze, coordinate and sustain research that has a direct impact on programs and policies aimed at reducing tobacco abuse and nicotine addiction" [my emphasis]. I think I smell a big, stinking pile of bias. No where in that mission statement do I get the sense that these people are adherents of the the scientific method. Science is about discovery, not enforcing an agenda. What if their research findings didn't support reducing tobacco use? Huh? I have a hard time believing that they would support any of the research promoted by these people (5). And seriously, could they have found an easier target to generate bad press about other than tobacco? Pedophiles maybe? Personally, I wish somebody would fund research on how to get these people (6) to shut up.

And just as an aside, Coke Zero (7) is Diet Coke (8) in a black can! Diet Coke has zero calories and zero carbs just like Coke Zero. All the ingredients are identical except for one, the artificial sweetener. Other than that, it's still Diet Coke! And to all you d-bags who claim that you can "taste the difference," you're not allowed to read this blog anymore. Seriously, get away from me, "Unwelcome touching! Unwelcome touching!" Go here instead (9).

Wednesday, October 8, 2008

Newsflash: Hot Flashes Are Treated by...Everything Too!

Welcome to the 6 o'clock news, I'm your anchor, Thor Buttocks. In a previous post (1), I neglected to mention Effexor's incest surviving son Pristiq. I came across this study (2), which was published earlier this year. The results from this pharmaceutical industry sponsored trial are not surprising, "Desvenlafaxine is an effective nonhormonal treatment for vasomotor symptoms in postmenopausal women." Case closed...unless you actually read beyond the abstract.

This was a 52-week long study (a rarity in psychiatry), which on the surface, sounds as if it could have generated a lot of good data. 707 healthy, postmenopausal women experiencing 10.9 hot flashes and 3.7 nighttime awakenings per day were randomized into one of five treatment arms: desvenlafaxine 50mg, 100mg, 150mg, 200mg, or placebo. The primary efficacy measures were completed at 4 weeks, at 12 weeks, and at...that's it. Out of 52 weeks, only efficacy data were gathered for 12 weeks. That's 40 weeks of data that are not reported. I wonder why? It certainly couldn't be that desvenlafaxine doesn't work that well. Surely not, no way, never.

First, let me say that these data can be trusted. Why did I say that? Because, according to this article, the "statistical analysis was carried out by the Biostatistics Section of Wyeth Research." Nothing like those good old in house (i.e., paid employee) statisticians to handle test data (it's a good thing you can't lie with statistics, 3). The "100mg/d produced a significantly greater decrease from baseline in the average daily number of moderate-to-severe hot flushes compared with placebo at both weeks 4...and 12...the desvenlafaxine 150mg group differed week 12....but not week 4...there was no significant difference from placebo for the desvenlafaxine 50 and 200mg doses at either time point." Additionally, there was a significant reduction in nighttime awakenings for the 100, 150, 200mg doses of desvenlafaxine compared to placebo.

Don't let the short phrase "statistically significant difference" fool you, because the differences are rather clinically insignificant. The 100mg dose produced the highest decrease in the number of daily hot flashes, averaging -7.23. The placebo arm was -5.50. That's a paltry difference of -1.73. The difference for the number of nighttime awakening is even smaller. -2.77 episodes for 100mg compared to -2.21 for placebo. That's a difference of -.56, one half of one full awakening episode (anything is possible with statistics). And of course, the desvenlafaxine groups had significantly more discontinuations and treatment emergent adverse events than placebo, thus justifying the use of desvenlafaxine to treat these symptoms.

What about those missing 40 weeks? How did placebo compare at the end of 52 weeks? I guess we will never know. Perhaps I am drawing a false conclusion here (admittedly, I'm biased), but if the results were significant beyond 12 weeks, I think the "scientists" would have reported those data. The remaining 40 weeks were ostensibly use to determine the "safety and tolerability" of desvenlafaxine (a noble goal that should have been accomplished in phase II trials).

A special thanks is also noted in this article "The authors thank Drs. Kathleen Dorries and Mary Hanson for assistance in the writing and review of this manuscript." I couldn't find any information on Mary Hanson, but Kathleen Dorries works for Advogent Group (4), which "create, deliver, and manage compliant communications and strategic solutions and services for the leading pharmaceutical, biotechnology and medical device companies." Apparently Kathleen Dorries has help write another paper on desvenlafaxine as well (5).

In summation, not only did the sponsor handle the management of the data, the manuscript was at least partially ghost written by people whose purpose is to "promote" rather than report. This study should be filed under infomercial, not science.