The Tale of the Two Millers

Today I’d like to tell two very sad tales, stories about suicide. One paints a very sad picture, the other, only half of one.The first story is about a depressed teenager.

In 1997, Matt Miller, a 13 year old started having behavioural problems; his grades dropped, he was banging his head against his locker at school, he began urinating on the bathroom floor. His parents, alerted to the problem by school officials, took him to an adolescent psychiatrist who diagnosed an unspecified depression. Since the boy did not show improvement after three weeks, the psychiatrist prescribed the anti-depressant Zoloft, a so called selective serotonin reuptake inhibitor (SSRI). A week later the young man committed suicide by hanging himself.

The parents suspected the medication played an important role in their son’s death and sued the maker of the antidepressant – pharma giant Pfizer. They enrolled the help of an expert witness, Dr. David Healy. Healy had studied the effects of SSRIs on individuals not suffering from depression and reported that a few had reacted with obsessive suicidal thoughts. Pfizer’s counsel argued that Healy’s testimony not be admitted because it did not meet the so called Daubert standards requiring judges to act as gatekeepers in the case of expert testimony and requiring evidence to have won “widespread acceptance” in professional circles. (This is the same standard defendants in the Kitzmiller vs. Dover case attempted to use in order to prevent Barbara Forrest from testifying. They failed and her testimony later proved damning to the Intelligent Design case.)

The second Miller story is not about someone who committed suicide, but someone studying it. Dr. Matthew Miller is the Associate Director of Harvard Injury Control Research Center and does research into methods for preventing suicide.

In a study appearing in the April issue of The Journal of Trauma, Miller is presenting his research into the correlation between the presence of firearms in households and suicide rates.

In the first nationally representative study to examine the relationship between survey measures of household firearm ownership and state level rates of suicide in the U.S., researchers at the Harvard School of Public Health (HSPH) found that suicide rates among children, women and men of all ages are higher in states where more households have guns. The study appears in the April 2007 issue of The Journal of Trauma.

“We found that where there are more guns, there are more suicides,” said Matthew Miller, Assistant Professor of Health Policy and Management at HSPH and lead author of the study.

Suicide ranks as one of the 15 leading causes of death in the U.S.; among persons less than 45 years old, it is one of the top three causes of death. In 2004, more than half of the 32,439 Americans who committed suicide used a firearm.

It should also be noted that there are more suicides in America per year than murders. It is clear that this study will be used by gun control lobbies to argue for more restrictions and attacked by firearm lobbies for being flawed.

While I am highly sceptical of handgun ownership, my alarm bells started ringing while reading the article describing the study. I got more suspicious when I read the summary,

The researchers recommend that firearm owners take steps to make their homes safer. “Removing all firearms from one’s home is one of the most effective and straightforward steps that household decision-makers can take to reduce the risk of suicide,” says Miller. “Removing firearms may be especially effective in reducing the risk of suicide among adolescents and other potentially impulsive members of their home. Short of removing all firearms, the next best thing is to make sure that all guns in homes are very securely locked up and stored separately from secured ammunition. In a nation where more than half of all suicides are gun suicides and where more than one in three homes have firearms, one cannot talk about suicide without talking about guns,” he adds.

Laudable sentiments all. But they only tell half the story.

You see, worldwide, America stands head and shoulders above the rest of the world with respect to access to firearms. There are many studies showing a strong correlation between the number of suicides, homicides and accidents using firearms. Unfortunately these studies usually don’t tell everything.

Let’s compare the data between Germany and the US. Germany requires firearms to be registered and gun owners to be licensed, both practices are handled in a patchwork fashion in the US. With only 8.9 percent of the households having firearms, Germany had a rate of 1.44 unintentional deaths by firearm per 100,000 residents (0.21 murders and 1.23 suicides) . During a similar reporting period, the US boasted a whopping 41 percent coverage of firearm availability with 13.47 firearm related deaths per 100,000 (6.24 murders, 7.23 suicides). This looks damning.

I would agree that data does point to a correlation between firearm availability and a direct increase in homicides. I think that is the paradox of the NRA argument of keeping weapons to defend oneself.

But if one concentrates on suicides, the picture changes. Let’s look at the overall suicide rate for the two countries. The US has a lower overall suicide rate than Germany (21.7 to 27.4 per 100,000).

Thus it would seem that any strong correlation between firearm ownership and suicide rates isn’t valid. What is valid is that if firearms are available, they will be used as the preferred method; but there are many, many ways to kill yourself.

So, even though I truly believe Dr. Miller’s heart is in the right place, I don’t trust his research. And any attorney attempting to use it in court will probably fail against an analysis similar to mine. Which brings me back to the first story.

Having research that only shows one side of an issue is one of the things that led to the creation of the Daubert standards. In the case of the suicide of Matt Miller the judge asked for help. According to the excellent Nation article about this,

To help evaluate Healy’s research, US District Court Judge Kathryn Vratil appointed two independent experts, Yale epidemiologist John Concato and University of Illinois psychiatrist John Davis, to answer her questions. “I had envisioned a freewheeling scientist-to-scientist dialogue,” says Vickery, the Millers’ attorney. Vratil, an appointee of the first President Bush, had other ideas: To avoid any appearance of bias, she barred the experts from talking with Healy or any other witness as they prepared their findings.

In their report, the two men called Healy an “accomplished investigator.” But they also said Healy’s methodology “has not been accepted in the relevant scientific community” and that the psychopharmacologist holds a “minority view” about SSRIs and suicidality. Agencies like the Food and Drug Administration (FDA), they noted, had found no such relationship.
[…]
In February 2002, Judge Vratil issued her key rulings in Miller v. Pfizer. “Dr. Healy is an accomplished researcher,” she wrote, “and his credentials are not in dispute.” But his belief in the SSRI-suicide link is a “distinctly minority view,” she added, and the flaws in his methodology “are glaring, overwhelming, and unexplained.” With that, Vratil rejected Healy as an expert witness–and dismissed the lawsuit against Pfizer. The Millers appealed all the way to the Supreme Court, which in October 2004 rejected their petition for a hearing.

It would seem that the minority opinion lost the day, a single researcher reading too much into the data. It would seem that Dr. Healy is analogous to Dr. Miller. Both had valid claims but were overreaching.

Dr. Miller correctly points out that the number of suicides using firearms is directly correlated to the number of firearms available. That does not lead however to the result that lowering the number of firearms will directly lower the number of suicides. If that were true, Germany should have a much lower rate of suicide than America indeed one would expect a dramatic drop. We don’t see that.

Dr. Healy looked at the data and worried about people being severely damaged by the very treatment meant to save them. Other researchers argued he was wrong. Perhaps the saddest factor in this story is that Dr. Healy was likely right. Returning to the Nation article

In April 2006 the drugmaker GlaxoSmithKline disclosed that adults with major depression were almost seven times more likely to attempt suicide after taking the SSRI Paxil than after taking a placebo, although these events were rare. In November an FDA analysis of 372 clinical trials, involving almost 100,000 patients, revealed a twofold risk of suicidal behavior for adults under 25 who took SSRIs. To those who share David Healy’s views, the latest research is an affirmation–too late for the Millers but perhaps early enough to avert future tragedies. “I believe it vindicates Healy in a major way,” says Antonuccio, the Nevada professor. “Here mainstream scientists are saying, Yes, these antidepressants cause suicidality–which is what Healy has been saying all along.”

So perhaps there is a more important moral here.

Sometimes, it doesn’t matter whether the science is right or wrong. Sometimes it might be better to err on the side of safety – licensing and regulating guns on the one hand and strictly controlling the use of SSRIs on the other.

But for many this kind of pragmatic solution comes too late and at a much too high a price; the high price of legal fees, lobbyists – and lives.

9 comments so far

  1. jeffreydach on

    According to Irving Kirsch in Prevention & Treatment , “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.

    Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

    1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

    2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

    3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

    4) Miscoding suicidal events as “emotional lability”, and homicidal events as “aggression” to hide suicidal events from regulators.

    5) False attribution of suicide to the placebo arm.

    6) Hiring ghost writers to make the medical articles more favorable.

    7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

    For more information and links see my Paxil, Prozac, and SSRI Induced Suicide Newsletter

    regards from Jeffrey Dach MD

  2. blc303 on

    Dr. Dach,

    Please don’t get me wrong here. You probably have something about your serious issues with SSRI induced suicides.

    Instead of getting linked to your newsletter, I would prefer you point me to all the other people supporting your findings. Especially for your points 1 to 7. There should be enough information availble. Right?

    Daubert demands it.

    And again. The jest of my entry was that your theory is argueably right. The question is can you show me support from other researchers?

  3. pamela on

    Hello :) I’m not an academic or a professional, so please bear that in mind re this message.

    Firstly, just to give more info on the Healy bit, he analysed the raw data on three drugs at least and all that wasn’t ‘confidential’ (maybe bits taken from courtroom appearances?) was given to the UK’s FDA (the MHRA). I’ll pick out the extracts that ‘matter’ but there’s far more information at the site this comes from for a clearer understanding:

    http://www.socialaudit.org.uk/58096-DH%20to%20WARK.htm

    Extract of correspondence from Professor David Healy to the UK drug regulatory body, the MHRA.

    “…Reports on these trials list patients who have committed suicide, and list those patients as being of a certain age and as having committed suicide at a certain point during the trial, when the patient in question has a very different age and the event in question happened at a completely different point during the trial”.

    “Miscoding of suicidal act as emotional lability.”

    ” Lilly have resorted to treatment non-response and a range of other headings to code what happened.”

    “…records on Prozac, Seroxat/Paxil and Lustral/Zoloft, you will find cases of homicidality coded as nausea for instance.”

    “Discontinuation of patients from studies for primary adverse effects such as nausea when in fact there has been a suicidal act;”

    “But it is also worth adding specifically that this has been a feature of all trials of Zoloft/Lustral, Seroxat/Paxil and Prozac throughout, as far as I can make out… ”

    Then as to support from other researchers:
    Many researchers depend on the industry for funding etc, medical schools rely on that funding. Funding’s down side is that it influences the what is taught and industry funded research tends not always to be as reliable as we take for granted. Healy was, I believe, once a consultant to the industry.

    Off the top of my head there’s another researcher (a forensic psychiatrist) who backs up what Healy’s research finds – and thats a Dr Lucire in Australia – who has also lost her post as a result.

    http://www.lucire.com.au/SSRIs_main.aspx

    The same thing happens in other drugs too, there’s an ‘exiled’ professor and researcher who lost his position because he asked to see the raw data of the research before ‘authoring’ a publication on a drug called actonel. It’s too complicated for me to summarise, but here’s his blog on the page that starts the Actonel part of it:

    http://scientific-misconduct.blogspot.com/search/label/Procter%20and%20Gamble

    There’s a number of reasons why finding researchers to back up information that the industry would rather not publicise, one being the influence the pharmaceutical industry have over doctors, another is that its more lucrative and takes a career further by complying with the industry’s wishes, and the other is obvious when you read what happens to those who keep their integrity – such as the last link above. Fear of losing career, credibility, etc.

    So its the ones with the courage to risk all that where the real picture is shown and its only a very small percentage that are willing to wreck their careers to protect ‘patients’.
    Which, given human nature, is somewhat understandable :)

    The FDA have strong financial interests in some way with the industry. The MHRA are paid entirely (100%) by the industry. So the watchdogs are paid by those who they are meant to be watching and whichever way you look at that its a strange state of affairs – and hardly a reliable setup.

    For the FDA situation, the documentary “Prescription for Disaster” is the one thing I can think of to post at the moment:
    http://video.google.com/videoplay?docid=-2502546838698762400

    As far as the shootings are concerned,
    there’s what I suppose would be called ‘anecdotal’ evidence as it would be impossible to prove beyond any doubt after the event that the drug actually caused the homicide, although Wyeth do have ‘homicidal ideation’ as a side effect of Effexor buried well down on page 40 of their pdf file here: http://www.wyeth.com/content/ShowLabeling.asp?id=100 and pfizer, though denying homicidal ideation as a side effect in homicide court cases, kept at least one report of it happening in clinical trials – as can be seen from the one that was leaked: http://scientific-misconduct.blogspot.com/2007/05/on-redefinition-of-research-misconduct.html …back to the ‘anecdotal’ evidence (nearly lost track there), then a lot of homicides that happened on this kind of drug as well as some that happened in withdrawal are in this pdf file: http://www.ssri-uksupport.com/homicidesSSRISandADHDmedications.pdf which I think about 30 pages long, and apart from the first page, each incident is just a few lines, so there’s a lot of incidents there.

    Then there’s evidence of how ‘reliable’ industry funded publications by experts are with the Zyprexa leaked documents found here: http://www.furiousseasons.com/zyprexadocs.html
    and various other industry and academic misconduct here: http://ahrp.blogspot.com

    It isn’t solely the industry’s fault either. To bring out masses of inaccurate information under the banner of ‘science’, it takes weak, or greedy, or frightened scientists to author those ppublications of ‘safety’ and ‘efficacy’. The industry is in the business of making money, the scientists are committing scientific misconduct, the universities require the funding, the drug regulators are a mix of those weak, greedy, frightened, AND need the industry money to do some of their work and finally there’s the role of the media, some of which know whats going on but put out the misinformation anyway. With them I expect its a question of greed though some reporters (anchors?) get fired for speaking up on the drugs issue – ergo fear too.

    I think this is a bit of a long post, I hope it isn’t too long :) pam

  4. pamela on

    The last comment hasn’t posted (at the time of writing this one) but if it does then this is a ps to it. Forensic psychiatrist Dr Lucire, mentioned in the other comment, has a file (or there’s a file on another site) here:
    http://www.ssri-uksupport.com/files/LuciredauberthearingonADs.pdf

    which does state:

    “The following is Daubert-competent
    Evidence, science that has passes 6
    Daubert Hearings

    that SSRIs (and other
    antidepressants) cause:
    Completed suicide
    Suicidal Ideation
    Suicidal Acts

    Two numbers are important
    RELATIVE RISK RR (of suicide)
    and
    SUICIDE RATE /100,000
    And the confidence interval (CI)”

    Maybe my last comment only needed to contain that article – I didn’t notice the “Daubert” reference until after I’d posted, sorry :)

  5. blc303 on

    I found your comments in the spam cache. Sorry.

    One problem is that people mistakenly think that you can keep your job as a scientist by doing good science.
    While I very much think that that is the way the world should work; I am also cognizant of the fact that it really doesn’t work that way.

    There are two problems. If you work in a private research lab, you have to research what your bosses tell you. Further your results belong to the company. That isn’t an environment that is terribly conducive to honest (negative) research. Think of the the tobacco researchers who got destroyed after quitting and going public with internal research.

    On the other hand, if you research at a university, although you might be “independent” in theory, you are still often required to find private funding for your research; especially in high cost areas like medical research. The most powerful researchers will be those who can drum up the most funding – those producing industry friendly studies.

    Is there a solution? I doubt it.

    I used the Zoloft/Matt Miller case as an example where I think research got it right and the courts wrong. I used a second example where I think the opposite is true. Science isn’t really easy. While I understand your frustration; I’m also probably not the blog to do information overload at.

    Thanks for stopping by. Have a nice day. Keep fighting your fight. Maybe, someday, you’ll get somewhere. :-)

  6. pamela on

    Thanks for posting, though there seems to be duplicates there – maybe I posted again in an attempt to get it show.

    Actually people ‘fighting the fight’ as you put it DO get somewhere, hence the changes that take place, such as age restrictions for certain drugs, black box warnings, drugs being taken off the market. And the same slow progress is made with regard to the science side of it.

    Enjoyed the stop-by thank you. You have a nice day too and rest assured that each day, people who are ‘fighting the fight’ will get a step further than they got yesterday. :)

  7. pamela on

    On the 27th when I did the comments, the first comment did not post, but the second one did, and so I assumed I don’t something wrong that the first had NOT and so I tried various other ways to get the ‘contents’ of the first to post.

    Had the 1st of my comments posted then although I’d have still have added the second comment (which DID post at the time) as it was to do with Daubert evidence, but I would not have attempted to cover the information again in different ways to get the comments to post. Any “frustration” (if you’re addressing me), would have been wondering why ONE comment posted (the second one, the ps re Daubert) and yet not the first or subsequent ones.

    So, ONLY what now show as the first and second of my comments were originally intended, and perhaps if you removed the rest/throw them back in the spam cache lol/just ignore the further ones — you’d see that its not quite the ‘information overload’ as it appears with several duplications :)

  8. blc303 on

    Hi Pamela,

    I killed the duplicates and tossed them into comment nirvana. ;-)

    I guess I think you’re attempting a Sisyphus task, rolling the pill up the legislative hill, just to have it roll down again.

    But like I say. Maybe you will get somewhere. :-)


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