Suicide Solution

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Yesterday the FDA issued a new warning for antidepressants that sets a disturbing regulatory precedent. Its advisory says: "Health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression and suicidality, especially at the beginning of therapy or when the dose either increases or decreases." The FDA is asking drug companies to include a prominent warning about suicide risk in their labeling.

But as The New York Times notes, there is little evidence that drugs such as Prozac and Paxil drive people to kill themselves:

Top F.D.A. officials have long insisted that their decisions are driven only by clear-cut evidence from well-run clinical trials. But in a conference call with reporters yesterday, agency officials said that no studies had shown a convincing link between drug therapy and suicide. Suicide is such a rare side effect that studies on the subject have been difficult to interpret, the regulators said.

Still, the agency issued the advisory anyway.

"It warns physicians that patients' depression may become worse," said Dr. Russell Katz, the agency's chief of neurological drugs, "that they may develop suicidal thinking or behavior after the initiation of treatment."

A series of secret studies, which were conducted by drug companies and became public last year, seemed to show that depressed children and teenagers given antidepressants were more likely to become suicidal than those given placebos. The studies also showed that most antidepressants were not effective in treating depression in children and teenagers. Those studies are still under review at the agency.

Nevertheless, a scientific advisory panel urged the agency last month to issue stronger warnings about the possibility that teenagers and children given the drugs could become suicidal. Studies in adults have found no link between the drugs and suicide, but the agency included adults in the warnings, in part because of anecdotal stories at advisory meetings last month. Dr. Katz said "a number of witnesses said that these were experiences that they had with adults, too."

"We think this is good advice whether the drugs did it or not," said Dr. Robert Temple, associate director of medical policy at the agency. "If someone commits suicide, it doesn't really matter whether it's the drug or the underlying disease. In either case, you need to pay attention."

Putting aside the issue of whether people who feel happier after taking antidepressants are suffering from an "underlying disease," the rationale for requiring the suicide warning is rather strange: Even if antidepressants don't raise the risk of suicide, the FDA is saying, it's a good idea to keep an eye on depressed people in case they decide to kill themselves. By this logic, the FDA could require a warning that a heart drug may raise the risk of myocardial infarction not because there's good evidence that it does but because people with heart disease should be closely monitored.

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  1. janine has a good point. i’ve heard it before and forgot all about it. i think that’s a rare case, though.

  2. There are a lot of things wrong with that FDA announcement (and with a medical establishment that has come to view SSRIs as complete treatment for depression, rather than as one piece of a treatment plan). What bugs me the most is that the FDA and the media have taken one study, which found a link between antidepressant use and suicide in youth and adolescents, and turned it into an issue for all antidepressant use, even among adults. The FDA’s sole source for expanding the warning to adults is anecdotal? That’s absurd. And how many news stories have actually drawn the distinction between adult use of SSRIs and kids? The fact remains that of the 10 drugs included in the announcement, only Prozac has been approved for use in pediatric depression.

    The real danger is that the FDA will be beaten into submission in the war against psychiatric medication that some, including Reason, seem insistent on waging. As one who has been treated for depression for eight years (currently on escitalopram), and suffered for far more than that, I would hate to see that happen. I suppose I could always go back on a tricyclic and suffer all the side effects that go with it.

  3. I’m a practicing clinical psychologist (22 years)and agree that the FDA warning is indeed ridiculous. Unfortunately it’s not just ridiculous. When you make a habit of issuing unnecessary warnings, the warnings turn into background noise. If, in the future, the FDA has a real warning to give about some medication based on real data and real dangers, the presence of this warning and possibly other bogus warnings will cause practicioners to pay less attention to future real warnings. It is not a good idea for the FDA to squander its credibility like this.

  4. if there is no evidence of suicide-depression link, which there is not, it is ludicrous and NC DAn is right on the money

  5. This is what you get when lawyers practice medicine

  6. Could we get a warning on FDA warnings? I have some anecdotal tales that it causes upset stomach, grinding teeth, and bruises on my head from banging the desk any time they come out with a pronouncement.

  7. This ruling by the FDA is absolutely ludicrous. As noted no studies show a link between anti’s and suicide and yet they issue the warning.

    I’ll give you one example. A person that I know very well has tried to commit suicide about 9 times that I know of. Should she start taking a new anti- and then kill herself, would it be the fault of the anti- or would the fault be the underlying DEPRESSION that this person has had all their life? Anti-s are given to depressed people, by definition, many with previous suicide attempts. To blame the anti- in these cases is simply ridiculous. But in our litigious society blame must be assessed so people can collect. That the FDA would give way to anecdotal stories and no clinical evidence is further evidence that the state of science in this country is simply shameful, as we can add this recent buffoonery to the ongoing stem cell, therapeutic cloning resistance. And it all starts with what Amy Alkon describes as our “Fundamentalist-in Chief.”

  8. Great. Another thing for the depressed to worry about. Thanks, government, for all the help!

  9. FDA: Simple minds seek simple answers? Anti-depressants are not a panacea; they are but one tool for treating depression. If there is a problem related to the anti-depressants in general, it is that they are often prescribed by themselves without any additional treatment (such as talk therapy, physical exercise, social interaction, etc.)

  10. this bs theory of “anti’s” causing suicide (ie, increasing depression) has been going around for more than 10 years. a lot of it (eg, the suit against the maker of prozac) has come from scientologists (all of whom are wacked out of their skulls). afaik, there has never been any real evidence (or study) that actually shows this.

    +1 to what chris volkay said above, about suicides possibly being blamed just cuz the person happened to be on an anti. it can take 6+ weeks for some antis to start working, so it’s possible people are even attributing suicides to antis before they even have any effect.

    i strongly suspect their is a majority of idiots who don’t understand how the scientific method works in the fda.

    part of the problem, though, is doing a controlled study would be very difficult and i wouldn’t put a whole lot of trust in the results. the reason is, depression can vary a lot between people and over time within the same person. it would be difficult to get an accurate measure of depression (other than “patient attemped suicide” – that obviously indicates depression). it’s hard to put a number on it, and even if you do, that number would change day to day.

  11. I need an anti-depressant after reading that.

  12. I am not a psychologist, but I have a BA in psych, and I researched depression extensively because I’m one of the millions who suffer from it.

    My understanding of the risk of anti-depresssants is as follows:
    One of the side-effects of depression, in addition to sadness, is apathy and inertia. A depressed person sees nothing to live for, etc., but has no energy to actually commit suicide. Anti-depressants begin to cure this apathy and inertia, and they can provide the ability for a suicidal person to find the motivation. They also are an unsteady path toward healing – one day the person may be feeling great, the next back in the depths of despair. This shock may trigger suicidal tendencies.

    The only solution to the unpredictible path out of depression, of course, is a watchful psychiatrist and caring friends and family.

  13. something no one has mentioned yet is the difficulty many people have in getting off of certain medications after being on them for years. anyone who has ever nursed someone through even a day or two of relatively mild withdrawal from paxil knows the score.

  14. Thanks Janine and dhex for explaining why the notion of anti-depressant use leading to depression is not necessarily ludicrous. Still, I would question the wisdom of adding the warning in lieu of research that shows a causal connection. And I agree with Sullum that the logic in that particular quote is flawed.

  15. Excellent point Donut Boy1965

    Best luck and keep fighting, Janine.

    Good thoughts Dhex.

    K

  16. Chris Volkay
    There is abundant evidence of a depression- suicide link. No responsible clinician would claim otherwise. My objection to the FDA warning is that it states the obvious.
    In order for a warning to actually function as a warning, it has to call attention to something that is not obvious to all. If the FDA attempts to “warn” practicioners about every conceivable danger, their “warnings” turn into background noise and no longer serve as real warnings.
    To put it another way, for warnings to actually accomplish something constructive, they need to be few and serious. Then they are noticed.

  17. It is documented that the IRS has driven people to suicide, so we need a warning on the IRS forms. It could be stuck in with the Paperwork Reduction Act Notice. “This form will take you 23 minutes to complete and may kill you.”

    It’s essential to eliminate the root cause of these IRS suicides: the income tax itself.

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