[SSRI-Research] What's in a Warning? Antidepressants and Risk of Suicide-FindLaw

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Mon, 26 Apr 2004 20:25:21 -0000

[sSRI-Research] What's in a Warning? Antidepressants and Risk of

Suicide-FindLaw

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting openness and full disclosure

http://www.ahrp.org

 

FYI

 

Contrary to the published reports in the peer-reviewed journals, the

preponderance of evidence demonstrates that antidepressants pose a

greater risk than a benefit for children. *[References below]

 

Informed medical treatment decisions hinge on the decision maker

having all the relevant information about the risks and benefits of

the treatment before weighing these against individual needs, medical

and psychological status, and available alternative treatments.

Sherry Colb, a columnist who is a Rutgers Law professor

notes: " Ideally, when a fully informed patient consents to a course

of treatment, then, she takes charge of her life and weighs competing

values in a manner that no one could do effectively in a state of

ignorance. "

 

Colb proceeds to lay out methodically the steps one needs to take to

weigh risks and benefits. Her analysis appears reasonable until you

realize it is fatally flawed when she addresses the risks and

benefits of issuing warnings about a suicidal risk of antidepressant

drugs. Colb makes an a priori assumption--without any evidence to

support it-assuming the drugs provide a " life-saving " benefit for

children. There is absolutely no scientific evidence that these drugs

prevent suicide. Indeed, the drug labels don't make that claim.

 

The suicide rate among adolescents has actually INCREASED since SSRI

antidepressants have been prescribed for youth. According to the

Center for Disease Control: " From 1980-1997, the rate of suicide

among persons aged 15-19 years increased by 11% and among persons

aged 10-14 years by 109%. Persons under age 25 accounted for 15% of

all suicides in 2000. For young people 15-24 years old, suicide is

the third leading cause of death (9.9/100,000), behind unintentional

injury and homicide. " See:

http://www.cdc.gov/ncipc/factsheets/suifacts.htm

 

See also: Hermann van Praag's survey: A Stubborn Behaviour: the

Failure of Antidepressants to Reduce Suicide Rates, World Biol

Psychiatry (2003) 4,

184- 191.

 

In point of fact, contrary to the claims made by drug manufacturers

and their partners in organized psychiatry, antidepressants have

consistently failed to demonstrate a benefit greater than placebo for

depressed children. This sobering fact coupled with evidence of a

litany of severe adverse drug effects led FDA's advisory committee

(Feb 2, 2004) to urge FDA officials to issue strong and explicit

warnings on these drugs' labels.

 

In the absence of persuasive scientific evidence demonstrating a drug

benefit, much less a " life-saving " benefit, ANY severe risk--such as

severe drug withdrawal syndrome, violent and suicidal behavior--no

matter how rare, is not justifiable when other, effective non-drug

therapies exist. In an equivocating April 8 editorial in The New

England Journal of Medicine, senior NIMH child psychiatrists,

Benedetto Vitiello and Susan Swedo

acknowledge: " Nonpharmacologic interventions, such as cognitive-

behavioral therapy and other psychotherapies, have been found to be

beneficial in children with depression. "

 

Most likely, Colb, like other Americans who are deluged with drug

advertisements, is under the spell of their influence. Her case

against warnings suffers from her failure to examine all the relevant

information about antidepressants.

 

Unlike prescribing physicians, the FDA had the relevant safety and

efficacy information for years, but senior officials did nothing to

inform the public until the British regulatory authorities banned

all, but Prozac for children.

 

Given the preponderance of evidence showing that the risks are

greater for children than any benefit, FDA's continued failure to

inform physicians and parents that the drugs have failed to prove

they are effective for the treatment of depression; FDA's failure to

issue unambiguous bold warnings that the drugs pose serious, though

rare, life-threatening risks, including suicidal behavior, is

irresponsible.

 

* Most recent analyses of the pediatric SSRI clinical trial data:

See: British Medicines authority:

http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages

/cemss

ri_101203.pdf;

 

See: Efficacy and safety of antidepressants for children and

Adolescents by Jon N Jureidini, Christopher J Doecke, Peter R

Mansfield, Michelle M Haby, David B Menkes, Anne L Tonkin, BMJ,

2004;328:879-883 (10 April) online at:

http://bmj.bmjjournals.com/cgi/content/full/328/7444/879?

 

See: SSRI in childhood depression: systematic review of published

versus unpublished data Craig J Whittington, Tim Kendall, Peter

Fonagy, David Cottrell, Andrew Cotgrove, Ellen Boddington, The

Lancet, . Vol 363 . April 24, 2004, 1341-1345.

 

Embargoed: analysis and recommendations of FDA's medical officer, Dr.

Andrew Mosholder

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

 

 

http://writ.findlaw.com/colb/20040421.html

What's in a Warning?

The FDA Hesitates to Link Antidepressants and Risk of Suicide

By SHERRY F. COLB

Wednesday, Apr. 21, 2004

 

A House committee is currently investigating the Food and Drug

Administration ( " the FDA " or " the Agency " ) for allegedly muzzling one

of its scientists, Dr. Andrew Mosholder, who has expressed the view

that the use of antidepressants is linked to suicide in children. His

view is based on an analysis of drug companies' research comparing

rates of suicide and suicidal gestures among depressed children

taking antidepressants versus placebos.

 

Dr. Mosholder's conclusions depart from those of the Agency and the

majority of its scientific advisors at this time. But if his

conclusions were ultimately accepted, they would lead - at a minimum -

to an FDA requirement that a warning label be placed on

antidepressants, revealing the link to parents who purchase the drugs

for their children.

 

FDA officials discouraged Dr. Mosholder from presenting his

conclusions at a February public meeting of the Agency's Advisory

Committee. Reportedly, they did so out of a fear of conveying the

impression that his views represented the Agency's formal position.

 

The Point of Warnings

Even medications that have been approved as safe are ordinarily

associated with some undesirable but unavoidable side effects or the

risk of such side effects that must accordingly be revealed to

consumers, in the form of a warning. (The same is true for surgical

procedures and other medical

interventions.) In a typical television advertisement for a medicine

that treats allergies, for example, viewers hear a (quieter and more

rapidly

read) list of medical harms that may befall those who choose to take

the medication.

 

Providing warnings for medical interventions serves a number of

objectives. First, individuals have a right to give or withhold their

informed consent, and part of what it means to be " informed " is to

know not only the potential benefits of an intervention, but also the

risks. By telling a patient of both the good and the bad that may

come from taking a particular medicine, the relevant health

professional or pharmaceutical company facilitates the patient's

exercise of autonomy.

 

If a proposed surgical procedure, for example, will excise a tumor

but may impair the patient's ability to sing, then an opera singer

may choose to forego the procedure and thereby allow her own values

to influence her choice of treatment. Similarly, a patient can choose

to leave his cancer untreated because the available medicines will

lengthen his days only by making them painful and nauseating.

 

Ideally, when a fully informed patient consents to a course of

treatment, then, she takes charge of her life and weighs competing

values in a manner that no one could do effectively in a state of

ignorance.

 

A second purpose for warnings is to allow members of an especially

high-risk subclass of patients to identify themselves and avoid the

medication in question. Birth control pills, for example, may carry a

risk of fatal blood clots for any patient who uses them. However,

women over 35 and smokers might be at a higher risk for such clots

than others in the population. Women who fall into this category

might therefore choose not to use the birth control pill at all or to

quit smoking before doing so -- and their doctors may, by the same

token, avoid prescribing the birth control pill to them.

 

In this sense, warnings serve both to separate potential patients

into different subclasses, based on the relative safety of medicines,

and to help patients avoid activities that are contra-indicated.

 

The Risk of Warnings

Like the medications about which they warn, warnings themselves carry

some risks. First, patients may be so frightened of the potential

side effects of an intervention that they refrain from taking a

useful medicine from which they would have benefited substantially.

(Put another way, unlike the presumptively rational patient who

calculates the weight of risks and benefits against the background of

her own value set, an actual patient may focus so much on the risks

of treatment that he fails to appreciate fully the potential costs of

having no treatment at all.)

 

A second risk of warnings is that they will overwhelm the patient

into passively accepting the recommendation of his physician. If a

long list of hazards is read to a patient, it may eventually become

difficult if not impossible to integrate each risk and assign it its

proper value.

 

Sometimes, in other words, having too much information can be as

disabling as having too little information. The difference is that

with too much, a patient may experience the illusory feeling of

having made a decision (one that he perhaps lives to regret) because

he did, after all, receive warnings.

 

Antidepressants and Suicide

How do the purposes and risks of warnings translate when it comes to

the potential for suicide among children who use antidepressants? Not

especially well.

 

Consider by contrast the case of the opera singer facing surgery to

remove a tumor - a case that pits the patient's desire to minimize

the odds of her cancer recurring, against her desire to avoid the

possibility of losing her voice. Unlike in this case, the parent of a

patient in need of antidepressants faces two versions of the same

risk. On the one hand, the child will, if left untreated, continue to

suffer from depression, a mental illness that, left untreated,

carries a serious risk of suicide. On the other hand, the child can

take a medicine that may increase the chances of suicide but may also

improve his condition and allow him ultimately to avoid suicide.

 

In this scenario, there is thus no real opportunity to allow one's

competing values to determine the course of treatment. If another

treatment plan, perhaps an alternative antidepressant, were effective

but did not carry a risk of suicide, then the values competition

might have a role to play -- particularly given the likelihood that

alternative treatments would carry distinct side effect profiles that

might have led doctors to avoid prescribing them to children in the

first place.

 

As to the second purpose of warnings, it does not appear that we can

know in advance of particular patients' using an antidepressant,

which patients are likely to become suicidal as a result. Indeed, the

determination of causation may be difficult even in those patients

who do commit suicide, precisely because this risk is associated with

both the disease and the cure. For parents trying to protect their

children who suffer from depression, then, the knowledge that

antidepressants can cause suicide will not give them guidance on

whether or not their child ought to be avoiding the medication.

 

There is one respect, however, in which warnings can be useful in the

prevention of suicide among those who take the medicine. Doctors who

prescribe antidepressants can make sure to monitor their patients

closely and watch for agitation and other indicators of potentially

suicidal inclinations. When a person is preparing to commit suicide,

there are often warning signs that a professional is equipped to

detect.

 

To the extent that a general practitioner or pediatrician simply

prescribes antidepressants without monitoring or even knowing how to

monitor for suicide risk, the warning could have the salutary effect

of motivating such a doctor to send her patient to a mental health

professional, rather than simply writing a prescription for an

antidepressant without further supervision.

 

As to the risks of warnings, it scarcely needs stating that if a

parent is terrified of a child's committing suicide, that parent

could make a terrible mistake by denying the child potentially life-

saving treatment in the form of antidepressants. Learning that taking

a drug may be lethal - whether the fatality is self-inflicted or not -

can be quite scary, and there is a substantial risk that the person

hearing about the potential lethality of a drug could be distracted

from the reality of the underlying disease. If that were to happen,

then the warning could lead to more deaths than it avoids.

 

And finally, there is the risk of passivity in the face of too much

information. The parent who hears about the risk of suicide might be

overwhelmed and simply direct the doctor to do what he thinks is

best.

 

In such a case, the parent may feel that she has made a decision

when, in truth, she has simply shut down in the face of threatening

facts. If the risk of the child's suicide ultimately does come to

pass, she may therefore be left unfairly blaming herself.

 

How Rational Are We?

The utility of warnings -- about antidepressants and other

interventions -- seems to turn, at bottom, on the degree to which

actual patients and their parents truly resemble rational calculators

who weigh risks and benefits against each other and make decisions

that are best suited to the patients' values.

 

In the case of suicide risk from taking antidepressants, it may turn

out that warnings do more harm than good -- because they decrease

drug-induced suicides only by increasing the number of suicides due

to depression, over time, to a greater extent.

 

Given this risk, it may well be that the FDA was justified in

attempting to prevent the premature public dissemination of the

disputed scientific view that children who take antidepressants are

at an elevated risk for suicide. In making its assessment, the House

Energy and Commerce Committee should accordingly take care not to

neglect the fact that warnings, like medicines, can have serious

detrimental side effects.

 

Sherry F. Colb, a FindLaw columnist, is a Professor at Rutgers Law

School in Newark.

 

 

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