Prozac, Suicide And Dr. Healy

Dr. David Healy of the Department of Psychological Medicine at the Universityof Wales in the UK is hardly a household name in the United States or elsewhereand that is a shame.

One of the world's leading research psycho-pharmacologists, Healy's experttestimony in last year's Paxil civil trial was one of the deciding factors inthe plaintiff's jury victory in that case.

(Wyoming resident Donald Schell, 60, killed his wife, daughter andgranddaughter and then himself with a gun in 1998 after only two days on Paxil.Schell's surviving family members sued Paxil manufacturer UK-basedGlaxo-Smith-Kline(GSK), the world's largest pharmaceutical manufacturer, andwon. The decisive factor in the case was the company's own internal datademonstrating that they knew Paxil could cause agitation and suicidal ideationin research subjects. A month after the June verdict in the case, GSK caved into the British Medicines Control Agency's request to put a suicide warning onPaxil)

The fact that a jury verdict in a civil trial here in the United States hasled to a suicide warning being put on labels for a popular psychiatric drug inanother country has hardly been headline news. Two weeks after the verdict inthe Paxil trial, Houston area mother and convicted murderer Andrea Yates drownedher five children while she was on not one, but two antidepressant drugs withstrong stimulant profiles.

What could have been an opportunity for the mass media to educate the publicabout the dangers of antidepressant drugs, instead has been a non-stop awarenesscampaign for the mental health industry about the need for more psychiatric"treatment." The real story that has been missed in the Yates case isthe fact that it is a story about psychiatric treatment failure. Yates had beengetting psychiatric drugs for her post partum depression for years. She was onhigh doses of two antidepressants drugs at the time she drowned her children butwent ahead and did what these drugs are supposed to prevent anyway.

Meanwhile, Dr. Healy hasn't shied away from linking Prozac, Paxil and theother SSRI's to suicide. He figures at least 250,000 people have attemptedsuicide worldwide because of Prozac alone and that at least 25,000 havesucceeded. He was offered a job at the University of Toronto affiliated Centerfor Addiction and Mental Health(CAMH) in 2000. Healy was making arrangements formoving his family to Toronto when he gave a lecture at the CAMH on November 30,2000 where he reiterated his position on Prozac and suicide. He also made a lotof other statements, backed up by statistical data, that are politicallyunpopular with many of his psychiatric colleagues. Such as the fact thatpsychiatrists have more patients in their care then ever before.

Healy was unceremoniously turned down for the CAMH job.

Speculation has it that Prozac manufacturer Indianapolis-base Eli Lilly mayhave had a hand in Healy's firing. An international controversy has ensued aboutHealy's case and the implications it has for academic freedom in academicmedicine. Healy filed a multi-million dollar breach of contract lawsuit againstthe CAMH and the University of Toronto on September 24 of last year.

A summary of the entire David Healy affair can be read on the web.

I recently completed an e-mail interview with Healy about Prozac and suicide,the CAMH lecture and many other contemporary issues in psychiatry today. Belowis the transcript.

RG: How do Prozac and the other SSRI's (Selective SerotoninReuptake Inhibitors) like Paxil cause suicidal ideation ("We can makehealthy volunteers belligerent, fearful, suicidal and even pose a risk toothers," you wrote in the June 2000 Primary Care Psychiatry. "Peopledon't care about the normal consequences as you might expect. They're notbothered about contemplating something they would usually be scared of)?

Dr. David Healy: There is a greater difference between Prozac andother SSRI's on the one side and placebo on the other side in the rate in whichthey cause agitation, than there is between Prozac and the other SSRI's andplacebo and the rate at which they get people who are depressed better(i.e. theSSRI's cause more agitation in testing subjects than sugar pills, but they alsotend to outperform sugar pills at getting depressed people better). The factthat companies have chose to market them as antidepressants rather than agentsthat cause agitation is a business decision rather than a scientific matter. Itis certainly not one that was "ordained by God." You could say thatthe fact that some people who are depressed get better is a side effect.

These drugs are drugs that primarily work on the serotonin system. There isno evidence for any abnormality in the serotonin system in people who aredepressed. There are however variations in the serotonin system in people whoare depressed. There are however variations in the serotonin system in all of usso that some of us will have quite different effects from these drugs thanothers. It would have been a relatively simple matter to do work on this 10years ago to find out which of us were more likely to have problems with thedrug than which of us were more likely to do well on them.

RG: You testified in the Paxil trial in Wyoming on behalf of theplaintiffs. The plaintiff's position in the case, vindicated by both the juryand judge in the case, was that Paxil was the primarily responsible for DonaldSchell shooting his wife, daughter and granddaughter to death before killinghimself with a gun in 1998. Schell had been taking the drug for two days. Basedon the internal Glaxo-Smith-Kline(Paxil's UK-based manufacturer and world'slargest pharmaceutical company) documentation you reviewed as an expert witnessin that case, what would you have to say about Paxil and suicide to anindividual contemplating a prescription for the drug?

DH: The evidence across the board from all of the companies producingSSRI's is that their drugs can make 1 in 20 of us agitated to the extent that wedrop out of trials. This agitation in some cases will include thoughts ofsuicide, self-harm or strange out of character thoughts. The agitation may evendevelop to psychotic proportions.

Part of the problem with SSRI's is the they have been prescribed to manypeople by a doctor who may not be aware of these side effects and may not havewarned you about the side effects. If you then develop problems on the drugs youmany not link the drug to the problem or you may feel now that you have a verysevere nervous problem that and your physician is the only way out of theproblem. A hostage dynamic can develop.

There is a particularly difficult scenario where a patient is faced with aphysician who tells them that any increased nervousness they now have is notbeing cause by their pills and that the answer to this is to continue with thepills. In this case many people may not even let the physician know how seriousthis increased nervousness is - as they feel they are not being listened to.This situation can arise in part because physicians are dependent on companiesfor information about any problems that can be caused by the drugs are informedthat there is no problem of this kind that stem from the drugs, that any problemof this kind stems from the illness. In such circumstances where a physician isrelying on what they have been told by the company and not listening to theirpatient, there is a real risk of things going badly wrong. Some people will onlyescape disaster if they halt their pills.

RG: The story of Houston area mother Andrea Yates drowning her fivechildren has led to quite a campaign of awareness about mental illness in themass during the past several months. First, it was post-partum depression andnow, with the recent revelation in the testimony in the Yates' murder trial thatshe believes she is possessed by Satan, schizophrenia. What hasn't happened withthe Yates case has been an honest accounting of what it really is about: Anothercase of psychiatric treatment failure. Andrea Yates' post partum depression hadbeen getting treated with drugs for years and she was on two antidepressants atthe time she drowned her five children. I'm not asking for much from the massmedia on the reporting of this case. Just the barest mention of two words withthis case would be helpful: Effexor and Remeron.

At the time of the drownings Yates was on 450 mg/day of Effexor, or 75 mgabove the maximum recommended dosage, and 45 mg/day of Remeron, or the maximumrecommended dosage. Yates had been taken off 4 mg/day of the tranquilizer Haldoltwo weeks before she drowned the children and the Remeron was added to herprescription, which continued to include the Effexor. Now there is a wealth ofclinical date out there about these two drugs but the media has to look at itinstead of helping the mental health industry promote mental health awareness.

It turns out that a gem of study titled "Mirtazapine(Remeron) VersusVenlafaxine (Effexor) in Hospitalized Severely Depressed Patients WithMelancholic Features" was published in the August 2001 Journal of ClinicalPsychopharmacology. It's a gem with regard to the Yates case not only because itcompares two groups of patients put on the same antidepressant drugs she was onat the time of the drownings, but because it does not omit the fact thatconcomitant medications were being administered to the patient/subjects(a rarityfor the published results of clinical studies, indeed).

Out of the group of 78 patient/subjects put on Remeron, 56 percent of themwere administered the benzodiazepine tranquiler Oxazepam to counter agitationand 35 percent were administered the hypnotic Zolpidem to counter insomnia. Outof the 79 patient/subjects in the Effexor group, 49 percent were administeredOxazepam and 41 percent were administered Zolpidem.

Here are the other vital statistics provided by the article: 62.8 percentof the Remeron group were female and 68.4 percent of the Effexor group werefemale. The maximum dosing of the Remeron group ranged from 45-60 mg/day and300-375 mg/day for the Effexor group. The study lasted eight weeks and 23.1percent of the Remeron group dropped out, plus 35.4 percent of the Effexor groupdropped out of the study.

Well, am I on to something here? Is it unreasonable to suggest that Yateswas suffering from extreme agitation and/or insomnia, given that she was takinghigh doses of both Effexor and Remeron, and that this might have been a factorin her actions the day she drowned her children? What do you know about Effexorand Remeron? (Effexor is known as a "Serotonin and Norepinephrine ReuptakeInhibitor" or "SNRI" and Remeron is known as a "Noradrenergicand Specific Serotonergic Antidepressant," "NaSSA")

DH: The European tradition had been that all antidepressants couldcause a problem. This included the tricyclic antidepressants which likeVenlafaxine (Effexor) inhibited both serotonin and norepinephrine reuptake. Theclinical trials of Mirtazapine (Remeron) submitted to the FDA that got it alicense contain an excess of suicides and suicide attempts in those trialscompared to placebo. I don't know the details for Venlafaxine (Effexor).

Your point about it not being unreasonable to suggest that Yates wassuffering from extreme agitation and/or insomnia on the combination of Effexorand Remeron is a reasonable one.

(At this point Healy thanks me for the reference to the study and asks mefor the name of the first study author in order to find out more details aboutit -RG)

RG: "No Such Thing As An Antidepressant" is the title ofone of the chapters of Peter Breggin's book The Antidepressant Factbook. Bregginwrites, "Is it possible that there is no such thing as a genuineantidepressant? Before the scientific data had confirmed my suspicions, Idoubted that a drug could actually 'treat' depression. After all, if depressionis a product of our conflicts, stressful life experiences, and stifled choices,a drug would have no direct effect on treating it. Meanwhile, study after studyhas confirmed that antidepressants typically perform only a little better thansugar pills. In some studies, antidepressants actually turn out to be lesseffective than the lowly sugar pill." Breggin then goes on to cite theclinical data in a review of the performance of seven antidepressants in 45clinical trials. Is there such a thing as an antidepressant drug and iscontrolled clinical testing anyway for us to answer this question?

DH: The Breggin line that there is no such thing as an antidepressantbecause depression arises from conflicts and you couldn't expect a drug to treatthat does not follow a coherent medical logic. The problem with a wide varietyof nervous states we are faced with is that we don't know the origins of these.To say that they arise from conflicts is too simplistic.

But even if they did arise from conflicts it is not clear that an entirelyartificial solution that had little to do with conflicts wouldn't be a way oftreating the problem. In many medical states from broken legs through to cardiacproblems the answer may be to insert something artificial like a metal plate ora plastic valve in order to produce a new modus vivendi. The origins of theseproblems are not a deficiency of metal in the leg or plastic in the heart butthe metal in one case and the plastic in another may provide a workablesolution. However, having said this antidepressants are not a cure in the sensethat they do not correct either the biological abnormality that may be involvedin depression or event the biological predisposition to depression. Someantidepressants are energy enhancing. Others like Zoloft, Prozac and Paxil aremore anxiolytic (anxiety relieving). This may or may not be helpful thing to doin the case of someone who is depressed.

Controlled clinical testing doesn't answer the question of whether there issuch a thing as an antidepressant or not. What trials do is to show whether adrug can do something or not. Whether it is wise to then do that something ornot is an entirely separate question and it is probably the case that manyclinicians don't take the time to make a clear decision as to the wisdom ofusing an antidepressant in the case of each of the patients that they ultimatelygo on to prescribe for. The overwhelming majority of who are prescribedantidepressants are at little or no risk for suicide or other adverse outcomesfrom their nervous state. Treatment runs the risk of stigmatizing the person aswell as giving them problems that they didn't have to being with.

RG: I'm looking at a copy of the August 2001 issue of PrimaryPsychiatry. Of course, it's filled with psychiatric drug ads almost exclusivelyfeaturing middle-aged and older female models. Most of the models are smilingwidely because of the happy pills they are on (Effexor, Risperdal, Remeron,Celexa, Vivactil). The Zoloft add features a portrait painting of a female facefilled with anxiety and depression. The Paxil ad features a model whose face isfilled with anxiety and worry, obviously because she hasn't had a prescriptionfilled for her happy pill yet(Of course, there is no suicide warning anywhere tobe found in the ad, which I assume is now required by law in the UK). There isone ad featuring a male model for the narcolepsy drug Provigil. In one frame theprofessional looking male model with thick glasses is overcome with fatigue. Inthe next frame he is as happy as can be with a wide smile across his face.

Has the aggressive marketing of psychiatric drugs as happy pills(to thegeneral public as well as doctor's in professional journals) over the pastdecade and-a-half turned MD's into Dr. Feelgoods?

DH: I spend a good deal of time cutting out adverts for psychotropicdrugs to use to illustrate my talks. The marketing of psychiatric drugs and thechange of climate that this marketing brings about has turned what used to bephysicians into what lawyers now refer to as pharmacologists. It has becomestandard practice in the US for you to get your drugs from a pharmacologist andto get therapy from a psychologist or counselor paid at a lower rate. This splitis, I would have thought, disastrous. It means that the people who monitor theimpact of therapy on you are not trained at all to know about the hazards ofthat therapy.

RG: Out of curiosity, I wonder if you have any analysis and/oropinion about Loren Mosher's Soteria experiment(This was an experiment indrug-free psychiatric treatment conducted under the auspices of the NationalInstitute of Mental Health during the '70s. The experiment went well by allaccounts. It's just that not only was Soteria drug-free, but Mosher staffed theexperiment with non-professional counselors. Soteria was quickly defunded andforgotten by the late '70s). I bring this up because I don't recall it beingmentioned in The Anti-depressant Era and it is a case often brought up bycritics of the politicization of clinical testing in psychiatry (The most recentexample being Robert Whitaker's book Mad In America).

DH: Unfortunately, although I have recently met Loren Mosher, Ihaven't analyzed or come up with a view on the Soteria experiment. This is anomission, particularly in the light of the fact that I have a new book out fromHarvard University Press this month on the antipsychotics called The Creation ofPsychopharmacology. It picks up many of the issues touched on in a variety ofyour questions but unfortunately not Mosher's Soteria Experiment.