Zetia, Paxil, Medical Journals, Fraud, Etc,

I've been busy wiping up tears after the Frontline episode on medicating children with a wide variety of psychiatric medicines. Well worth watching. There are many thoughtful comments over at Furious Seasons. Feel free to add your voice. I may post on some of the highlights and lowlights of the Frontline piece later. Suffice for now to say that it sure is depressing that the media keeps up the dunce journalism of linking decreased SSRI prescriptions to an increase in suicide as if this was some sort of reliable finding. Please read my earlier posts (1, 2) for details on this constantly repeated yet incorrect interpretation of events.

Here are a few other posts worth reading:

• Is "symptom remission" a realistic or even desirable goal when treating depression? A very interesting battle of letters in the American Journal of Psychiatry receives excellent coverage at Furious Seasons.
  
• Roy Poses at Health Care Renewal demolishes an op-ed piece by Robert Goldberg (from the infamous Drug Wonks site). Also check out an incredible tale of kickbacks to a physician from multiple companies. If your hunger for bizarre tales in healthcare is not yet satiated, read about CellCyte, a company whose main product is apparently fraud.
• Are medical journals asleep at the wheel regarding problems with Zetia? Aubrey Blumsohn seems to think so, and I think he might have a point. It would not be the first time that a medical journal dropped the ball.
  
• Paxil for life. Go ahead, try to quit. What, you can't quit? A large group of individuals suing GlaxoSmithKline believe they've had difficulties quitting Paxil without significant problems. Worry not, friends, GSK said: "We believe there is no merit in this litigation... Seroxat has benefited millions of people worldwide who have suffered from depression.'' Read more about Paxil/Seroxat's special benefits. H/T: PharmaGossip.
  
• While you can catch up on the national presidential derby from many sources, there is little coverage of the race for American Psychiatric Association president. Daniel Carlat (who is popping up everywhere these days, which is a good thing) provides his take on the upcoming APA election. To nobody's surprise, some have noted an issue with one candidate's potential conflicts of interest.
  
• Pfizer = McDonald's + Estee Lauder?
  

NIMH Gets Dunce Journalism Award

I have pilloried the study published in the American Journal of Psychiatry in September 2007 that purported to show that fewer SSRI prescriptions for kids in the USA was associated with an increase in the youth suicide rate for American youth. I quote from my earlier post below:

Look closely at the above graphs (click to enlarge) from the article. Note that the decrease in SSRI prescriptions from 2003 to 2004 was very slight across the 0-10, 11-14, and 15-19 age groups, which is the timeframe in which suicide rates for those aged 5-19 increased notably. The larger declines in SSRI prescribing for youth occurred from 2004-2005, which happens to be when the suicide rate for those aged 15-24 appears to have decreased from 10.3 per 100,000 (see Table 9; page 28 here) to 9.8 per 100,000 (see Table 7 here). Yes, I know I am comparing data for ages 15-24 to data on ages 5-19, but I think this makes sense when one considers that the suicide rate for those 14 and under is much lower than for those aged 15-24. Actually, grouping suicide data for ages 5-19 makes little sense to me given the vast differences in suicide rate within this age group.

It is important to note that the authors of the paper did not have data from 2005, but there is nothing from the 2003-2004 U.S. SSRI prescription data cited in their paper that even suggests a relationship between decreased SSRI use in youth and an increased suicide rate, as the decrease in prescriptions was minimal. Pay close attention: The authors ran a total of zero statistical analyses to examine the relationship between SSRI prescription rates and suicide rates in the United States. That’s right, zero. So they put up a couple of figures without a single shred of statistical evidence, then claim that declining SSRI prescriptions are associated with an increase in suicide rates. Any peer reviewer who was not drunk or on a high dose of Seroquel should have noticed this gigantic flaw.

Various newspapers and websites dumbly ran with this story using descriptions such as:

Warnings that antidepressants may increase teen suicides appear to have backfired, a new study suggests...

Suicide rates for preteens and teenagers increased sharply when the Food and Drug Administration slapped a "black box" warning on anti-depressants and doctors started writing fewer prescriptions for young people, according to federal data released Thursday

...and others. Please read my earlier post regarding idiotic media coverage of this article for details.

Enter NIMH: In a story datelined September 19, 2007, Jules Asher wrote a story for the NIMH website. As of today, it is still available. It mentions that

...based on mathematical models using previous years' data, the authors predicted an 18 percent increase in youth suicides between 2003 and 2005.

And, as mentioned above, this prediction turned out to be incorrect. Youth suicide rates in 2005 showed little change from 2004. Perhaps the NIMH writing staff could throw that little tidbit of information into an updated version of the article? Earlier in the piece, it is mentioned that

NIMH grantees Robert Gibbons, Ph.D., University of Illinois at Chicago and J. John Mann, M.D., Columbia University, and colleagues, make a case for a possible link between changes in prescription patterns, regulatory warnings and suicide rates in the September, 2007 issue of the American Journal of Psychiatry.

Again, note that they did not make much of a case in that the only statistical analysis they presented was from the Netherlands, yet they apparently believe such data generalized to the US as well. And remember that their own graphs contradict their argument and that the 2005 preliminary data on suicides also contradicts their arguments. The reason I am ranting/raving here is because I expect better from an allegedly nonpartisan organization that is dedicated to science. Why publish a story on the NIMH website pushing results from a study that is so full of holes that I could drive a fleet of Mack Trucks through it? Did the NIMH run stories publicizing findings of more credible research showing a link between SSRIs and increased suicide attempts? Nope. Kind of makes one wonder to what extent NIMH is an objective organization dedicated solely to advancing science, doesn't it?

Major hat tip to an anonymous reader who passed along the link to this wonderful article.

SSRIs, Suicide, and Dunce Jounalism

Earlier in the week, I noted that a much-ballyhooed study purporting to show a relationship between an increase in youth suicide and a decrease in SSRI prescriptions for youth actually did no such thing.

Here's what the media are saying about the study. WARNING: If you don't want to be shocked by examples of terribly poor journalism, please do not read the remainder of the post.

From the esteemed British Medical Journal:

"Numbers of suicides among Americans aged under 19 years rose by 14% from 2003 to 2004 , the study says, the biggest annual increase since systematic recording began in 1979. The same year saw a 22% decrease in the number of SSRI prescriptions to this age group."

The increase in suicide rates appears to be accurate. As I pointed out earlier, the youth suicide rate then apparently dropped slightly in 2005, which is when SSRI prescriptions for youth fell steeply. As for SSRI prescriptions dropping 22% -- that number is inaccurate. Look at the chart (pardon the crappy image quality) and note that the SSRI prescription rate for youth in the U.S. was down only slightly in 2003-2004, not by 22%. Bad journalism.

From the Washington Post:

The trend lines do not prove that suicides rose because of the drop in prescriptions, but Gibbons, Insel and other experts said the international evidence leaves few other plausible explanations.

Again, if you folks want to rely solely on correlational data (which is a stupid idea in any case), then you may want to make sure that a statistical analysis is actually run which shows a relationship between SSRI prescriptions and suicide rates. Read the whole WaPo piece if you'd like -- it's not terrible overall.

From WebMD:

Warnings that antidepressants may increase teen suicides appear to have backfired, a new study suggests...

"The FDA has overestimated the effect of antidepressant medications on suicidality and dramatically underestimated the efficacy of antidepressants in the treatment of childhood depression," Gibbons told WebMD in April 2007.

Oh, he must be referring to the efficacy that shows, at best, a small effect over placebo. Indeed, the recent meta-analysis by Bridge and colleagues that claims it showed the benefits outweighed the risks for SSRIs even showed a very small treatment effect favoring SSRIs in depression for youth. Indeed, most SSRIs did not show any advantage over placebo. How does one "dramatically underestimate" a treatment that provides an apparently pretty small benefit over placebo? And if you really love to rely on correlational, epidemiological data, then try this on for size -- the data do not indicate that SSRIs decrease suicide.

How about the Chicago Tribune?

Suicide rates for preteens and teenagers increased sharply when the Food and Drug Administration slapped a "black box" warning on anti-depressants and doctors started writing fewer prescriptions for young people, according to federal data released Thursday.

This one will be covered in a moment...

The headline in the San Francisco Chronicle:

Suicide rise follows antidepressant drop: Study finds dramatic increase after 'black box' warning

As I noted earlier, the black box warning occurred in October 2004, and I know of not one shred of data that can track that particular time point to a "dramatic increase" in suicides. Hell, Gibbons and colleagues did not even attempt to link an increase in suicides to that particular date, yet the media latch onto this point as if it is mired in solid scientific data.

And one more from the Los Angeles Times:

The study, which includes data from the Netherlands, provides the strongest evidence yet that the drugs are useful in preventing suicide, Gibbons said.

So, to make this clear, the "strongest evidence yet" is based upon a report of correlational data where, for the main population studied (the United States), there was not even a single statistical analysis done to relate a decrease in SSRI prescriptions with an increase in suicide rate? This, my friends, is bad science that has now become "the truth" thanks to science writers who either don't know a damn thing about science or are unwilling to challenge the opinions of the scientists whom they interview. It also becomes "the truth" when Gibbons, in interviews, is making statements that run far past what his own data show. Scientists can have opinions, but one needs to separate what is based on solid data from what is speculation.

By all means, read my prior post that dissects this latest study and let me know if I missed something. In my opinion, the Gibbons study was uninformative at best and appears to have led to a large number of poorly reported stories. At this point, a few bright individuals appear to have indicated that my take on the article is accurate (1, 2, 3).

To be fair, The Boston Globe and New York Times get a pass -- their coverage of the issue was excellent.

For a great brief read on another youth suicide study, visit The Last Psychiatrist.

Update (9-25-07): Via Furious Seasons -- An op-ed in the Boston Globe by Alison Bass blasts the latest media blitz regarding the alleged link between declining SSRI prescriptions and increased suicides. Furious Seasons wisely notes a couple of small errors in the Globe piece, but the overall thrust is well worth a read.

Suicide Update

Psychiatric News, the newspaper of the American Psychiatric Association, has caused me a traumatic brain injury. How? Well, after reading the following, I hit my head against a wall so hard that I probably damaged at least 85% of my brain. Why?

The paper is beating the drum over the supposed relationship between a) the FDA placing a warning about the link between suicidality and SSRI usage and b) the subsequent increase in teen suicides. To arouse the ire of its audience, the piece stated:

"This is very disturbing news," said David Fassler, M.D., an APA trustee-at-large and a child and adolescent psychiatrist in Vermont. "The current data suggest that the decreased use of these medications is, in fact, associated with an increase in actual deaths attributable to suicide."

David Shern, Ph.D., president and CEO of Mental Health America, echoed Fassler's concern.

In the article, nobody was interviewed who took an opposing view. Better yet, there was no data presented in the article that the FDA warning actually led to a decrease in SSRI prescriptions for youth. As I have attested to in two prior posts on this issue, the data do not actually support that SSRI prescriptions for youths declined when the FDA issued its warning. So if prescription rates did not go down, kinda hard to say that declining prescriptions led to more suicides.

Yet note how the mainstream psychiatric press and the mainstream media have reported this issue -- it's a pro-drug circus where science is omitted so that a panic can better be created. Funny how there are never a lack of "key opinion leaders" who are willing to step up and opine on these issues despite having no data to back their assertions.

Update: Turns out there were data indicating a decline in SSRI prescriptions, though this information did not become public knowledge until much later. But, it appears that despite decreased SSRI usage, suicide rates fell slightly in 2005.