Emperor SSRI has no clothes

Dr. Weeks Clinic:   Some straight thinking about the relative worthlessness (compared to placebo or exercise or vitamin B shots or even tryptophan) of SSRI antidepressants. And yet more difficulty getting straight answers about … side-effects.

The Antidepressant Dilemma

The latest news about antidepressants and depression is worth taking seriously
Published on January 9, 2010

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It was surely only a matter of time before blowback began over the latest round of news about antidepressants. I was just surprised by the speed with which it came.

Last Wednesday, CNN and several dozen other news agencies reported that “milder depression may not respond to antidepressants.” A study published in JAMA that day had asserted, “There is little evidence that [antidepressants] have a specific pharmacological effect relative to placebo for patients with less severe depression.”

This was news, no matter how one spins it. True, the JAMA study involved a relatively small number of patients (718), and for six-week trials rather than six-month ones, but it also focused on randomized, placebo-controlled trials, which makes it legitimate, if not exactly earth-shaking, and a study to take seriously rather than to dismiss out of hand, as some now seem intent on doing.

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The findings don’t mean that antidepressants don’t work,” CNN was careful to report, “only that most of the drugs’ effectiveness in people with milder depression can be attributed to the placebo effect.”

Certainly, some news outlets didn’t report the full story. ABC News titled its report, “Study: Antidepressants, Placebos Nearly Effective,” which is only half-true, and misleading in terms of the findings over chronic depression. But the study does raise serious questions about the well-established pattern of prescribing antidepressants for minor depression and other mild disorders. It also calls the effect of antidepressants on those with even moderate depression “negligible.” That’s quite a statement, coming from the journal of the American Medical Association.

If you read Judith Warner’s op ed “The Wrong Story about Depression,” in the New York Times today, however, you might come away with the impression that the issue concerning medication and minor depression isn’t sufficiently serious to worry about. Apparently, it’s just blather and hype about overmedication; and it concerns only general practitioners rather than psychiatrists (well, that’s a relief to know!). It may take some moments to recall that the last big story about antidepressants was that the drugs are linked to major personality changes, not all of them predictable or entirely welcome. In the news cycle before that, the headlines were that “Antidepressants May Raise Women’s Stroke Risk,” and so on.

While acute, Warner’s perspective turns out to be entirely one-sided. It focuses exclusively on chronic depression, where antidepressants have been shown to have some efficacy, but leaves aside questions that inevitably support what’s long been known: that antidepressants have limited-to-zero efficacy for those with mild depression. Yet the drugs have been prescribed to that population in very high numbers (in June 2005, as I’ve reported before, the International Review of Psychiatry estimated that the total amount prescribed in the U.S. alone has been to upwards of 67.5 million people, almost one fifth of the general population).

After reading Warner’s column, you might almost come away thinking that the black-box warnings added to Paxil, Prozac, and other SSRIs the previous year, which were meant to stop the drugs from being prescribed to children because of a disturbing pattern of increased suicide ideation, were just matters drummed up by pharma critics like me, rather than a concern brought by the Food and Drug Administration, a concern the agency had been monitoring years before it decided to act. You might also wonder why the issue about antidepressant efficacy in mild depression is considered news now, more than two decades after the SSRI revolution in the late-1980s, when the FDA began approving those drugs for the first time, on the grounds that they were safe and effective. Since then, Americans have received literally billions of media impressions urging them to “ask their doctor” about taking antidepressants for mild depression. Also not a concern, right?

Let’s not forget that Big Pharma financed “public-awareness campaigns” for drugs such as Paxil that were more expensive than even comparable ad campaigns for Viagra ($92.3 million v. $89 million in the year 2000 alone). Let’s also not forget that corporations such as GlaxoSmithKline, maker of Paxil, knew about problems concerning the drug’s limited efficacy quite a few years before it received FDA approval in March 1999 for the treatment of social anxiety disorder.

We know about these things because we have documents proving that the drug companies chose to “spin the problem” so that they could capitalize on reaching the largest possible audience. Yes, Judith, even when that meant hiring ghostwriters to plant positive but fabricated research in reputable medical and psychiatric journals. The markets for mild depression and mild anxiety are not small or trivial. For the drug companies, there are billions of dollars at stake in ensuring that that market remains as open to treatment as possible.

The moment even a JAMA review of randomized control trials points to well-documented concern about overuse of antidepressants for those with less severe depression, however, apparently we can now expect rapid blowback from Judith Warner and others, mischaracterizing critics as saying that antidepressants are just “happy pills that don’t work” and that we should beware of being “primed to believe stories of psychiatric trickery.” That’s such a misleading analogy. The JAMA article isn’t about psychiatric trickery; it’s a forthright report on two slightly different, similarly important, and far from mutually-exclusive concerns.

Americans are understandably conflicted over these and other reports about antidepressants; there’s a real and understandable dilemma over whether to prescribe or take antidepressants for what the DSM and other diagnostic guides represent as mild disorders. We need reporting that weighs both sides of this complex issue, rather than trying to play up only one angle and dismiss every other. The JAMA report concluded, “For patients with very severe depression, the benefit of medications over placebo is substantial.” Point taken. But that doesn’t rule out its other statement, that “there is little evidence that [antidepressants] have a specific pharmacological effect . . . for patients with less severe depression.”

Before there’s a stampede to try to keep patients on medication they may not need (and may never have needed in the first place), a lot more research and careful investigation is needed to weigh the implications of those two statements.

Meanwhile, it’s striking that commentators like Warner can never bring themselves to mention the rather serious matter of side effects, especially from SSRI antidepressants and antipsychotics (now marketed for depression with bipolar disorder). The narrators of pharmaceutical ads hurry through such side effects just seconds before the end of each commercial. You know them: They start with sexual side effects, an understandable concern for roughly 70% of affected patients on SSRI medication, then move to talking about the risks for pregnant mothers, and end up warning you not to take the drug if there’s a risk of heart attack, stroke, blood-clotting problems, and several other widespread medical conditions. Those, too, are based on serious studies. We can’t overlook that inconvenient truth in the effort to steer the conversation exclusively to chronic depression. Americans need to hear and assess the full story, warts and all.

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