But you cannot sue the regulators [The FDA are unreliable wimps]

I despise the citizens commission for human rights and their overly emotive, over the top, propaganda about psychiatric medications. I also hold the average member of the FDA in contempt, for they look at data but not at people. And they over react, often driven by brain dead activists (ie. Scientologists and their useful idiots) and miss the science.

And this can cost lives.

Screenshot - 190614 - 20:40:12

The FDA warnings received a flood of media coverage that researchers said focused more on the tiny percentage of patients who had experienced suicidal thinking due to the drugs than on the far greater number who benefited from them.

“There was a huge amount of publicity,” said Stephen Soumerai, professor of population medicine at Harvard Medical School and a co-author of Wednesday’s study. “The media concentrated more on the relatively small risk than on the significant upside.”

The researchers pointed to headlines in publications such as the New York Times (“FDA links drugs to being suicidal”) and The Washington Post (“FDA confirms antidepressants raise children’s suicide risk”), that, they wrote, “became frightening alarms to clinicians, parents and young people.”

As a result, antidepressant prescriptions fell sharply for adolescents age 10 to 17 and for young adults age 18 to 29. At the same time, researchers found that the number of suicide attempts rose by more than
20 percent in adolescents and by more than a third in young adults.

Researchers tracked the rise in suicide attempts by examining reports of non-fatal poisonings involving psychiatric medicines — a common indicator of attempted suicides. They said the likely number of suicide attempts probably was much higher, given that the study didn’t account for other suicide methods and poisonings that went unreported.

“There was a sort of overreaction by the media, but also an excessive caution on the part of patients,” said Christine Lu, a Harvard Medical School researcher and co-author of Wednesday’s study. “Lots of people who needed treatment steered clear because of the fear factor .?.?. For any drug, there are risks, for sure. But there’s also the risk of leaving the underlying condition untreated.”

Wednesday’s findings are in line with research published in 2007 that documented a precipitous drop in antidepressant prescriptions in the wake of warnings from federal regulators.

That study, published in the American Journal of Psychiatry, found that the sharp decrease in antidepressant use coincided with an increase in the number of suicides among children.

At work I am quite cautious about prescribing antidepressants for adolescents and children. Firstly, I’m an adult psychiatrist, and I prefer these people are seen by my child psychiatrist colleagues — I only see them in emergency situations. Secondly, these medications do not work fast — but the side effects do happen fast. Thirdly, there is a lot of data about talking therapy, including child friendly internet based talking therapies being effective in this age group.

But some people need medications, and often there is a moral panic based around those evil doctors, pushing evil pills. When everyone “Should have therapy to understand what is going on”. [The fact that most evidence based therapies do not explore early life events has somehow never got into the mainstream. Freudian therapy is now only practised by true believers, and for most Freud is studied for historical interest only].

But regulations have consequences, including a change in suicidal acts, not suicidal thoughts. It took some time for most of us to stop listening to the FDA — even in NZ — and treat our patients.

But we have stopped listening to the FDA completely. They have lost our trust, our respect, and we instead turn to other sources of information. Such as the literature (good) or the pharmaceutical companies. I will leave it in the reader’s mind to consider if that is less good.

13 Comments

  1. Maeve said:

    Both my late brother and my SIL worked for a major pharmaceutical company (she is still in the industry; the things they have told me about how and why potentially good therapies cannot get to the marked just makes me want to weep.

    June 20, 2014
    • chrisgale said:

      True. Do not start me on PHARMAC — we have a monopoly drug purchasing agency, whose job is keeping the drug costs down and nothing else.

      June 20, 2014
      • Wiless said:

        IIRC, New Zealand is the only other country other than America which has prescription pharma advertising on TV permitted.

        June 21, 2014
      • pukeko said:

        It is, but government funding is very restricted

        June 21, 2014
      • chrisgale said:

        Yes. But the government does not fund branded medications if there is a generic available.

        June 22, 2014
      • Wiless said:

        Fund in what capacity? Not sure I follow.

        June 23, 2014
      • pukeko said:

        Most medicines are paid for by the state as part of the health budget with a five dollar part charge to the patient regard less of the real costs.

        June 23, 2014
  2. Bike bubba said:

    So a reduced prescription of SSRIs and other antidepressants led to an increased rate at which teens used the same to attempt suicide? Am I reading that right? It would also seem that, if 2% of teens are on the drugs and .02% teens attempt suicide with them, that 1% of those who take the drugs attempt suicide with them–barring non-depressed teens trying to kill themselves with SSRIs and the like, of course.
    Am I reading this close to right? It reminds me of Disraeli’s “Lies, damned lies, and statistics”, Deming’s “In God we Trust, all others must provide data”, and the “post hoc, ergo propter hoc” fallacy. To the last, I would have assumed that depressed people would be more likely to attempt suicide–it’s not even clear that elevated rates of suicide among people with SSRI use demonstrates what they were trying to say.
    And yeah, if I’m reading this correctly, sounds like the FDA needs some help with logic and statistics.
    BTW, most of my wife’s siblings have been, or are, on SSRIs. Not to try to put you and your colleagues out of business, but is there something that a non-psychiatrist can do to lend a hand? Just seems like an average psychiatrist has maybe an hour a week with an ordinary patient, the family has the other 167.

    June 20, 2014
    • chrisgale said:

      In short, yes. The same finding was found in Europe and has been know for some years, but we now have US data.
      The trouble with suicidality is that is is answering “sometimes” to one question in the depressive outcome scale. This is not an overdose. The trouble is that about one in 100 suicides succeed.

      In NZ, we lose (population 4 million) about 540 people a year from suicide, which is about twice the death rate from road crashes (240 a year) and that, by the way, is with faity strict gun regulations.

      And, Having had to deal peripherally with the FDA (You will use this dose — us, no, that will not work –repeat for a year) they do get in the way of things getting on the market. Such as salbutamol (Ventolin).

      You guys have too many rules and regulations, and I say that living in NZ, which has the fastest lawmakers in the West.

      June 20, 2014
      • Bike Bubba said:

        Agreed on the regulations. BTW, I’m looking up the overall stats–NZ is close to the U.S., really–and any idea what’s led to some pretty huge drops in Switzerland and Sweden, while Norway’s rate skyrocketed? Just ran a p test and the shifts appear to indicate something happened.

        http://en.wikipedia.org/wiki/Suicide_in_the_United_States#mediaviewer/File:Suicide-deaths-per-100000-trend.jpg

        And I’m guessing it would take a little more “doing” than just a quick “good morning” answer like you’ve just provided, but sometime I’d love to see your thoughts on what family members can do for the depressed. I’ll look through your site, too, in case you’ve already addressed this.

        June 20, 2014
      • chrisgale said:

        You are quite right, that was a good morning and only one cup of coffee reply. The suciide rate is not one of my research interests, but I know those who do this in NZ.

        The issue is very political down here as well, with a few nasty issues around unavailabilty of MH services. Responding to the international rates is actually and academic paper, but the one hint from the NZ research is that the issue is not necessarily untreated depression alone. Among men, the issues relate to disengagement. Look for increased sucide rate with unemployemnt (Demonstrated back in the 1980s in scotland during Thacther’s time) and alienation from the larger society.

        And in the USA, look at PTSD. One colleage was a military psychiatrist and left the VA because after every war the suicide rate in veterans is sky high for 10 years.

        A final hint before I have to go to work: the rates (annual prevalence) of anxiety and depression combined in tEnglish speaking coutnries is around 15% and it is more like 7% in Germany &c using the same instrument.

        A fuller answer would need to be a medical hypothesis, and my employer would want me to publish that :-)

        June 20, 2014
      • Bike Bubba said:

        I think I’m following you–when someone drops out of life, especially a man, watch out, and the converse would be that even a dumb quality engineer like myself can lend some tiny help by checking in with people, whether or not I’ve got the skill of determining whether someone is actually dropping out. And I’d guess about the same for orderliness (“Ordnung!”) in a society.

        And of course I wouldn’t want to put you out of a job, so when you publish something interesting and get paid for it, I’ll be eager to see what you’re up to. Even if I don’t totally get it. :^)

        June 21, 2014

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