Complaint against Medsafe on the matter of antidepressants for adolescents

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Journal of the New Zealand Medical Association, 14-December-2007, Vol 120 No 1267

Complaint against Medsafe on the matter of antidepressants for adolescents

For over a year, local child psychiatrists have become increasingly concerned about the Medsafe’s position on the use of SSRI antidepressants in adolescents and its failure to correct its position when informed of accumulating contrary evidence.

Because of this, on September 18, 2007 I filed a complaint on behalf of local psychiatrists with the Minister of Health as set out below. I received an immediate acknowledgment from the Minister saying that I would receive a reply as soon as possible.

On November 2 I reminded the Minister that I had not yet had this reply and again received an acknowledgment dated November 7 that I would receive a reply as soon as possible. To date nothing further has been received.

One can be forgiven for believing that Medsafe is unwilling to front up in the hope that our complaint will disappear without trace into the Wellington morass. I consider that this behaviour is both unethical and contrary to the public weal.

However, I leave readers to judge.

18/09/2007
Rt Hon Pete Hodgson Minister of Health	cc Dr Jackie Blue MP Editor NZMJ RNZ National

We wish to make a formal complaint against the Ministry of Health’s Medsafe with respect to its recent public utterances on the use of Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants in adolescents. While initially, Medsafe grudgingly admitted that one SSRI antidepressant (fluoxetine) might be useful, though only when other treatments had failed, in the last year or so it has at least twice publically made comments to the effect that the risk of using SSRIs in adolescents outweighs the benefits. We have contested these utterances in a number of ways on the grounds that this position does not reflect the medical research facts. We have had no response and so we are appealing to you to get Medsafe to modify its statements to reflect the medical facts.

We ask this not just because Medsafe’s position is scientifically untenable, but because it is deterring doctors in NZ from prescribing antidepressants, causing unnecessary anxiety in patients and families, limiting patient choice, and (arguably) increasing the risk of youth suicide.

As noted Medsafe initially agreed that fluoxetine might be used in some cases but only as a second-line treatment. This ordering is inconsistent with the facts which show that fluoxetine is superior to other treatments (March et al 2004). It is an unacceptable paradox that as the evidence for the value of fluoxetine has grown stronger, Medsafe has in fact extended its proscription!

Scientific evidence supports our view that SSRI antidepressants (notably fluoxetine) can be both safe and effective in the treatment of certain psychiatric conditions of adolescence as follows:

Depression—unipolar and bipolar types with or without psychosis.
Obsessive compulsive disorder (one SSRI is approved by the US FDA for this use and in children as well as adolescents).
Some Anxiety/Phobic disorders especially in autism (this is tentative only).

However, we shall confine our comments to adolescent depression as that is by far the commonest use of these medications in adolescents.

We contend that Medsafe’s draconian position is depriving patients of choice and is, in some cases, statistically the best treatment.

Fluoxetine (Fluox), an SSRI antidepressant, has been shown to be an effective (if not the most effective) treatment for adolescent depression (Hettrick et al 2007).
It is true that there are other treatments for adolescent depression most notably cognitive behaviour therapy (CBT). While CBT seems to be favoured by Medsafe, there is an inconvenient truth about this treatment. The best study (March et al 2004) so far of over 400 adolescents with depression, showed that the SSRI antidepressant fluoxetine response (60.6%) was significantly superior to that of CBT (43.2%). There are other issues too—not all patients will respond to CBT (especially those with the severe forms of depression), and some may do better with a combination of CBT and medication (March et al 2004), though this has not been found by others (Goodyer 2007), and some prefer medication or will not engage in CBT.

Medsafe continues to emphasis the risks rather than the benefits, but we contend that the risks are significantly less than the benefits (60.6%).

The scientific evidence around risk shows as follows:

The reputed increase in suicidal thinking and acts is by no means clear and disputed by two good studies (see March et al 2005; Goodyer 2007). What this means is that if this effect is real, it is small and difficult to detect and overshadowed by a large beneficial effect.
There is no evidence to support the view that SSRIs have caused any increase in actual youth suicide - anywhere. In fact, as the number of prescriptions in NZ of SSRI antidepressants has risen dramatically in adolescents over the past five years or so, the youth suicide rate has declined significantly. While we do not wish to claim that these events are causally related, it not unreasonable to so conjecture.
A recent study in one of the top psychiatric journals shows that as the prescribing of SSRIs has fallen due to official warnings (in the US and the Netherlands), there has been a rise in youth suicide rates (American Journal of Psychiatry 2007).
In the March et al (2007) study, while the rate of attempted suicide was higher in the fluoxetine group, it also occurred in the CBT group. It is by no means certain that the process of CBT may not in itself stress patients and cause an elevation in suicidal thinking. There is, in fact, an old unproven adage in psychiatry that the most dangerous time for suicide is in the recovery phase of depression. There is no a priori reason that this should not affect CBT too.
Depression has been shown to be a risk factor for youth suicide. While this is not the only risk factor is it one of the most treatable. Anything which detracts from an evidence based treatment for depression (fluoxetine) would be predicted to increase the risk of youth suicide.

Finally, the history of psychopharmacology shows that generally drugs within the same class (e.g. SSRI antidepressants, antipsychotics) nearly always turn out to be much the same differing only in side effects and kinetics. Only fluoxetine has been robustly trialled so far and it is likely that at least some of the other SSRI antidepressants will eventually be shown to have a place in the treatment of adolescent depression. While we do not at this stage wish to argue for any other SSRI antidepressants, when and if evidence of their value comes forward, we do not wish to have to have to fight the same battle over again.

We consider that Medsafe’s position of actively discouraging the use of SSRI antidepressants like fluoxetine in youth is not only inconsistent with the scientific knowledge but it constitutes a potential health threat to the youth of this country and deprives them of the right of informed choice of treatment.

We ask that Medsafe issue a statement as follows admitting that:

It has misinformed the public about the use of SSRIs ,notably fluoxetine, in adolescent depression, by overstating the risks and minimising the value.
Its opinion was formulated knowingly over the objections of the child and adolescent psychiatrists of NZ.
In the treatment of adolescent depression an SSRI antidepressant, fluoxetine, has been shown to be effective with a clinically significant effect size (Hettrick et al 2007).
CBT and fluoxetine are of probably comparable efficacy, though at the moment the evidence favours the superiority of fluoxetine. Thus both treatments, either separately or in combination, should be considered as the primary treatments of adolescent depression (Hettrick et al 2007).
Some patients will prefer, be suited and have access to CBT but others will need medication as treatment of first choice because they prefer it, are unable to cooperate with CBT, have no access to CBT or have depression of such severity that CBT is vitiated.

John S Werry
Child & Adolescent Psychiatrist
(j.werry@auckland.ac.nz)

For the NZ Branch of the Faculty of Child Psychiatry of the RANZCP

References:

American Journal of Psychiatry 2007;164:1356–63.
Goodyer I et al: BMJ. June 11 2007.
Hettrick S et al: Cochrane Library 2007 No 3.
March J et al: Journal of the American Medical Assn 2004: 292:807–20.