Some of you may remember that I (along with Jackie and the support of many others from the Heroicagencies List) took issue with a Newsweek article about a study published in the July, 2008 issue of American Journal of Psychiatry. (For the full story, visit http://chemicalimbalance.org) The study looked at two variables: SSRI prescription rates and suicide rates and compared these in various age groups. The authors suggested that a drop-off in prescribing caused by the Black Box warning led to increased suicide rates.

Newsweek was one of the media outlets that enthusiastically supported the study’s claims. Their article, “Trouble in a Black Box” was written by Tony Dokoupil.

We sent an email to the author and the editor of Newsweek pointing out the problems with the article. The problem was that an examination of the study revealed that the “parallel” development was not parallel at all. A graph in the study clearly demonstrated that the precipitous drop in prescriptions occurred after the increase in suicides. As you read this exchange, keep in mind that everything we pointed out was eventually acknowledged by both the New York Times and The Boston Globe – but not Newsweek.

Dear Editor:
Please find below our letter in response to the article, “Trouble in a Black Box.” Our examination of the study forming the basis for the article revealed a glaring inaccuracy–the study’s results do not match the findings reported in the Newsweek article. Given that very few individuals read or understand research, we believe it important for Newsweek readers to be aware of this discrepancy to evaluate the necessity of the Black Box warning:

Tony Dokoupil’s Trouble in a ‘Black Box’ (July 16) importantly addresses the risks and benefits of prescribing antidepressants to children. However, the referenced study is far from “compelling” evidence for removing the FDA Black Box warning and such an interpretation of its findings is misleading. An inspection of this industry funded study reveals that the precipitous drop in SSRI prescriptions did not occur, as reported, from 2003 to 2005 but rather from February to October of 2005 (over 85% of the drop in the last 6 months of the reported time). The so-called “parallel development” of increased suicides occurred between 2003 and 2004—and therefore had no relationship to the drop in prescription rates reported in this study. Given that the decrease in prescription rates and increase in suicides occurred in different time periods, it begs the question of how such unsubstantiated statements could be made by the experts cited in the article.

Only 3 of 15 clinical trials have shown antidepressants to be superior to a sugar pill on primary measures. Children and parents in those 15 studies reported no advantage of antidepressants over a sugar pill. Data from the FDA and its British counterpart demonstrate that children and adolescents taking antidepressants are twice as likely to experience suicide-related events. Given the meager results and increased risk for suicide-related events (as well as other serious adverse events), antidepressants are not a good first choice for youth struggling with depression—a conclusion reached after an extensive risk/benefit analysis conducted by the American Psychological Association’s Work Group on Psychotropic Medication

Dear Dr. Duncan:
Thank you for responding to my recent story, “Trouble in a Black Box.” In answer to your concerns, I writing to let you that the important “parallel development” we had in mind was that child and adolescent use of antidepressants dropped (for the first time since coming on the market) while suicides rose significantly for the first time since the late 1970s. The fact that antidepressant use dropped most steeply in 2005, the year for which suicide data is still forthcoming, may merely foreshadow trouble–which is why the FDA is concerned. “The evidence is very compelling,” they say.
Tony Dokoupil

Dear Mr. Dokoupil:
Thanks for your note. I understand the proposed relationship between the increase in suicides and decrease in prescriptions that your article and the cited experts were asserting. But the evidence for such a relationship is far from “compelling” when the two developments occurred over different time periods. Your article and the cited experts gave the impression that the “parallel development,” as the word “parallel” suggests, occurred during the same period and therefore were related to one another. This was quite misleading given that an inspection of the study and its graphs revealed something quite different. Had you only commented that it could be a foreshadowing, and offered other explanations, then the article would have not so misrepresented the data. I would appreciate your clarification for Newsweek readers or that my letter be published.

Dear Ms. Lichtschein and Mr. Dokoupil:
I would greatly appreciate knowing your decision regarding our letter. It is of course your perrogative to print or not print any letter you receive. In this case, however, we believe it is critically important for you to get the facts straight because of the unfortunate misrepresentation of the data reported in your article. It is particularly troubling given the bold and even outrageous comments made by the cited experts which, at times, bordered on hysteria and fear mongering, far removed from an objective interpretation of the facts. Perhaps an interesting story would address how the drug company affiliated researchers responded to the findings as a “parallel development” while understanding full well that the precipitous drop in their study occurred after the increase in suicides.

Dear Dr. Duncan,
We appreciate your concerns, but don’t have plans to run your letter. We feel that the story adequately expresses the available data, which concerns the simultaneous snapping of two 15 year trends. The fact that the sharpest drop in antidepressant use occurs in the year for which suicide data is still forthcoming is significant, but more significant in this context is the reversal of a steep, longstanding trend toward increased SSRI use. We also sought comment from experts with interests on all sides of the issue.
Tony Dokoupil

Dear Mr. Dokoupil:
Thank you for your response. Just for the record, you are stating that you will not print our letter because “the story accurately expresses the available data.” We have, in fact, shown that, based on data from the cited study, it does not. The “simultaneous snapping” of the two trends is clearly neither simultaneous nor “parallel” as your story and letter depict. Nor is there enough available evidence to make any definitive statement about youth suicide trends for the time frame mentioned. Perhaps you “sought” consultation from experts on both sides. However, you did not publish both sides. Nowhere in the story are there opposing points of view or other possible interpretations for any trends the existing data might foreshadow. We must assume that, based on your refusal to publish a valid and important counterpoint, it is your intention to keep counter voices from your readers. Not only does this do a disservice to your readers, it walks a perilous line. It reflects how a major media source can, through biased reporting, create unjustified fear and potentially influence the repeal of a warning label implemented, after extensive scientific debate, to protect children. It is our belief that any observer of this process may likely view it as we do—representative of neither balanced nor ethical journalism, especially as it involves a life-and-death issue impacting our nation’s youth.

Thus, while The New York Times and The Boston Globe addressed the problems Newsweek never did. Strike one.

Particularly egregious were the comments in the Newsweek article by Robert Vuluck: “You may induce two suicides by treatment, but by stopping treatment you’re going to lose dozens to hundreds of kids. You’re losing more than you’re saving. That’s the calculus,’ says Dr. Robert Valuck, of the University of Colorado Health Sciences Center.”

While sloppy journalism and lack of fact checking is expected from the media, the bold and even outrageous comments that Valuck made went well beyond just an unfortunate misrepresentation of the data. His comments bordered on hysteria and fear mongering, far removed from an objective interpretation of the facts and offered a conclusion from the data that he must have known, as a study co-author, to be false. This is a serious ethical violation because it created unjustified fear and could potentially influence the repeal of a warning label implemented, after extensive scientific debate, to protect children. This was neither balanced nor ethical science especially as it involves a life-and-death issue impacting our nation’s youth.

Researchers, especially those funded by corporate interests have to be held accountable. We tried to hold him accountable but the University of Colorado Committee on Research Ethics (CRE), specifically, John E. Repine, M.D. who informed us that the CRE did not find sufficient evidence to warrant an inquiry. Strike two.

That’s the past. But these things happen all the time. Case in point. Consider an article just out in the New Yorker:

http://www.newyorker.com/arts/critics/atlarge/2010/03/01/100301crat_atlarge_menand  

It is a review of two new books about antidepressants. It has many redeeming qualities in that it acknowledges the problems with diagnosis and the research suggesting that antidepressants are no more effective than placebo. But it’s all downhill after that, and begins making a not so hidden argument for antidepressants. It purports to do a pro/con analysis of the drugs and psychotherapy but makes two incredulous omissions. One is that it doesn’t discuss, at all, the adverse effects of antidepressants; and two, it fails to mention long term comparisons between psychotherapy and medication. Finally the article cites (and significantly misrepresents) the STAR*D study to support antidepressants, and to refute the claim that SSRIs are no better than placebo.

After I read it, there was no turning back. I had to respond. Do any of you know a cure for that? I included Jackie and my analysis of the STAR*D study from the new Heart and Soul of Change. Given it calls into question their fact checking, I doubt it will be published. Strike three, Barry, yer out!

Here it is:
In the entertaining review, “Head Case,” Menand effectively covered the controversy surrounding psychiatric drugs. Two important issues, however, relevant to assessing the risks and benefits of psychiatric medication were omitted: the significant side effect profile of antidepressants and the poor performance of antidepressants in the long haul (especially as compared with psychotherapy). The STAR*D study illustrates. In the STAR*D, the average remission rate based on the primary outcome measure was 28% and 25% on the first two levels, and 14% and 13% on the last two. At Level 1, 28% experienced moderate to intolerable side effects. At Level 2 (participants augmented or switched), 51% experienced side effects ranging from moderate to intolerable. For all levels, 24% exited due to drug intolerability. Data from the 12-month follow-up of those who either remitted or responded indicated a relapse rate of 58%. Menand’s review omits the significant number of STAR*D drop-outs and claims that a 67% effectiveness rate after all levels. This figure was apparently derived by cumulatively adding percentage rates across levels, a practice statistically meaningless and certainly misleading. Since the rates of effectiveness are calculated from the numbers of participants in each level, average, not cumulative percentages correctly reflect overall improvement. For example, in the first two levels, out of a total of 4,168 participants, 1114 achieved remission, a 27% effectiveness rate, not the 56% rate reported by Menand. When drug studies are reported, original sources must be examined to insure that risks and long term follow up are considered.

Hope to see you soon in New Orleans!