Showing posts with label Christopher Lane. Show all posts
Showing posts with label Christopher Lane. Show all posts

Friday, October 26, 2007

SSRIs, Anxiety, Kids, Suicide, and Credible Evidence

I wrote a while ago about Christopher Lane's assertions that social anxiety was overdiagnosed and overtreated, particularly among children. Many people disagreed with Lane. One person who disagreed was Dr. Ronald Pies, a psychiatrist at SUNY Upstate Medical Center, who wrote in the New York Times that
... there is no credible evidence to support Mr. Lane’s implication that S.S.R.I. antidepressants are linked with increased risk of suicide in children prescribed these medications for social anxiety. The Food and Drug Administration’s initial concerns stemmed from studies in children with major depression, not anxiety disorders, and the latest evidence has not supported a strong link between S.S.R.I.’s and risk of suicide.
I re-read the latest summary of evidence regarding SSRIs and suicide in kids. Mind you, the article that I referenced (Bridge et al., 2007 in JAMA) came to decidedly pro-SSRI conclusions -- I didn't get my evidence dropped to me from a black helicopter. Based on trials submitted to the FDA, as reported by Bride and colleagues, there were data that pertained directly toward Dr. Pies' assertion. Here are the data regarding SSRI's and suicide in children and adolescents with anxiety disorders.

Note: AD represents Antidepressant; PL represents Placebo
Condition
Suicidal Ideation




Suicide Attempt/Preparatory Action
OCD
AD: 3 of 362
PL: 1 of 339




AD: 1 of 362
PL: 0 of 339
Non-OCD Anxiety Disorder
AD: 5 of 573
PL: 0 of 582




AD: 1 of 573
PL: 0 of 582
Total for Anxiety Disorders
AD: 8 of 935
PL: 1 of 921




AD: 2 of 935
PL: o of 921

Compare the odds of having suicidal ideation on drug to the odds of having suicidal ideation on placebo. Kind of a large difference, eh? I realize that the odds of developing suicidal ideation are still small, even on medication, but they are substantially higher than a child taking placebo.

While one could point out correctly that the difference is not "statistically significant," I think one would be foolish to fall back on that argument. We have seen in adults and children that SSRIs are related to more suicide attempts and that this finding is pretty consistent across trials, at least among children and young adults. When events occur rarely, then we need exceedingly large samples in order to be quite certain that the event (such as suicidal ideation in SSRI trials for anxiety in kids) is not an anomaly. But when kids are being treated for disorders that are very rarely associated with suicidality, yet the children show a much higher rate of suicidal ideation on a drug compared to a placebo, does it not make sense to warn patients about such potential hazards? One could run to the less SSRI's cause more suicide argument, but that hasn't really held up so well scientifically.

In my eyes, the above data represent "credible evidence" that SSRIs can indeed lead to an increase in suicidal thoughts among kids with anxiety disorders. Either Dr. Pies was unfamiliar with the above evidence or he believes it is not credible.

No actual suicides were recorded during the trials. Of course, if someone got worse during the study, then quit the study and killed himself/herself, then who knows if such data were included. Perhaps such events occurred -- I don't know. And there was much more supervision of these kids in a clinical trial then you'd see in real life, which could have kept some people from suicide. Further, let's suppose that the drug causes a child with social anxiety to become suicidal. He does not make an attempt on his own life, but he is suicidal for a month. Doesn't prior suicidal thinking predict later suicidal thinking and later attempt of suicide? So even if the child makes no immediate attempt on his life, couldn't he be at higher risk down the line? Maybe I'm losing my marbles, but I think it's a reasonable question.

Related posts on SSRI's and suicide:

Monday, September 24, 2007

Shyness: Pathological or Normal Experience

SmikeKlineBeecham/GlaxoSmithKline, the psychiatric elites who devised the Diagnostic and Statistical Manual of Mental Disorders, and social phobia. An interesting combination. I read a fascinating op-ed in the New York Times by Christopher Lane , an English professor at Northwestern University that discussed the growth of social phobia, especially among kids. Here are some highlights...

"How much credence should we give the diagnosis? Shyness is so common among American children that 42 percent exhibit it. And, according to one major study, the trait increases with age. By the time they reach college, up to 51 percent of men and 43 percent of women describe themselves as shy or introverted. Among graduate students, half of men and 48 percent of women do. Psychiatrists say that at least one in eight of these people needs medical attention.

"But do they? Many parents recognize that shyness varies greatly by situation, and research suggests it can be a benign condition. Just two weeks ago, a study sponsored by Britain’s Economic and Social Research Council reported that levels of the stress hormone cortisol are consistently lower in shy children than in their more extroverted peers. The discovery upends the common wisdom among psychiatrists that shyness causes youngsters extreme stress. Julie Turner-Cobb, the researcher at the University of Bath who led this study, told me the amounts of cortisol suggest that shyness in children “might not be such a bad thing.” [Not sure that this finding in itself is strongly suggestive of anything important, but it's interesting.]

Lane goes on to write about his perception that the diagnostic criteria are too loose for social phobia. Then, enter Paxil.

Then, having alerted the masses to their worrisome avoidance of public restrooms, the psychiatrists needed a remedy. Right on cue, GlaxoSmithKline, the maker of Paxil, declared in the late 1990s that its antidepressant could also treat social anxiety and, presumably, self-consciousness in restaurants. Nudged along by a public-awareness campaign (“Imagine Being Allergic to People”) that cost the drug maker more than $92 million in one year alone ($3 million more than Pfizer spent that year promoting Viagra), social anxiety quickly became the third most diagnosed mental illness in the nation, behind only depression and alcoholism. Studies put the total number of children affected at 15 percent — higher than the one in eight who psychiatrists had suggested were shy enough to need medical help.

This diagnosis was frequently irresponsible, and it also had human costs. After being prescribed Paxil or Zoloft for their shyness and public-speaking anxiety, a disturbingly large number of children, studies found, began to contemplate suicide and to suffer a host of other chronic side effects. This class of antidepressants, known as S.S.R.I.’s, had never been tested on children. Belatedly, the Food and Drug Administration agreed to require a “black box” warning on the drug label, cautioning doctors and parents that the drugs may be linked to suicide risk in young people.

You might think the specter of children on suicide watch from taking remedies for shyness would end any impulse to overprescribe them. Yet the tendency to use potent drugs to treat run-of-the-mill behaviors persists, and several psychiatrists have already started to challenge the F.D.A. warning on the dubious argument that fewer prescriptions are the reason we’re seeing a spike in suicides among teenagers. [Note that I tackled this recently.]

It goes on to close with...

With so much else to worry about, psychiatry would be wise to give up its fixation on a childhood trait as ordinary as shyness.

To view the diagnostic criteria for social phobia, please go here. Here is a key symptom:

"The avoidance, anxious anticipation, or distress in the feared social or performance situation(s) interferes significantly with the person's normal routine, occupational (academic) functioning, or social activities or relationships, or there is marked distress about having the phobia."

The diagnosis depends to a large extent what the doctor considers as "interferes significantly" or as "marked distress." When Paxil was being pushed, I'd be willing to bet that the reps were given scripts that helped to expand the boundaries of social anxiety disorder. When words like "significantly" or "marked" are used, one has to wonder what they mean? Who shapes physicians' judgment on these matters? To a notable extent, physician perceptions are influenced by commercials, er, continuing medical education and cheerleaders, er, drug reps.

A great piece from the New Republic in 1999 relevant to the expansion of social phobia can be found here. The points raised in the article ring true today. Let me be clear: I've seen real social phobia -- it exists and it is painful. But does it really affect 13% of Americans? I think not. I'm quite glad that Dr. Lane is stepping into the fray. I'm not sure I agree with him wholeheartedly, (I'll have to read his upcoming book first), but I know that I'm glad someone is willing to bring these issues to the fore. At the very least, this is a subject worthy of debate and discussion, not blind acceptance of the current orthodoxy that social phobia (like everything else) is underdiagnosed and undertreated.