October 26

Did Zoloft make him do it? FDA Zoloft data

Did Zoloft make him do it? FDA Zoloft data

Tue, 8 Feb 2005

At issue beyond a Charlsteon, SC court, is whether Christopher Pittman – who was 12 years old and under the influence of Zoloft, a powerful psychotropic drug, when he killed his grandparents–should have been charged with murder and tried as a competent adult? Or, whether he should have been charged with manslaughter for the crime committed by a (possibly) deranged 12 year old?

FindLaw columnist, attorney Elaine Cassel, discusses the broader issues that this case raises.

“the Pittman case is an indictment of both our medical system and our legal system — supposedly both the world’s finest. Our medical system let a 12-year-old down when it allowed a doctor to legally prescribe for him a drug that may well have caused him to have hallucinations and delusions – including the delusion that he heard voices commanding him to commit horrific crimes.”

“Our legal system now is letting a fifteen-year-old down by pretending that he is what he plainly is not: an adult. This toxic combination suggests that it is not just Pittman, but society, that may be in need of a cure.”

Both the drug safety oversight agency (FDA) and the medical / mental health establishment failed to meet their professional and public responsibility. They failed to ensure that the drugs prescribed for a 12 year old do not have hidden hazards that may trigger violent behavior. Evidence of the potential hazards of SSRI antidepressants is contained in the results from company controlled clinical trials, published case reports–and in FDA’s database of adverse drug reports filed with FDA’s MedWatch.

AHRP requested an epidemiologist who has access to FDA’s Medwatch database through June 2004, to search for Zoloft.

Using FDA’s preferred terminology to describe aggression, hostility and violent behavior, the following reports were filed*:

Aggression………………… 303 reports

Homicie ideation………….. 34 reports

Hostility ……………………372 reports

Irritability …………………169 reports

Paranoia …………………. 189 reports

Personality disorder……….225 reports

* It is unknown whether each or several reported effects refer to a different individual.

When one considers that only 1% to 10% of adverse events are reported to the FDA, and millions of people are on the drug, there are potentially thousands of hostile, aggressive, even homicidal individuals who pose a threat to themselves and others.

Until March 22, 2004, these serious adverse drug effects have not been disclosed to prescribing physicians or the public although instances of these adverse effects occurred during clinical trials and were known to these drugs’ manufacturers. When the public got wind about evidence of these drugs’ potential harm, the FDA responded by issuing long-overdue label warnings – including a Black Box warning about the increased risk of suicidal behavior in children.

On March 22, 2004, the FDA has required the label of Zoloft and the other antidepressants in the SSRI and SNRI class to include warnings about:

“the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression… as well as the emergence of suicidality in adult and pediatric patients being treated for major depressive disorder and other indications both psychiatric an nonpsychiatric.”

Pfizer continues to deny the scientific evidence demonstrating that Zoloft poses safety hazards as described in the FDA-approved label. See: Pfizer’s statement about the Pittman case: http://www.courttv.com/trials/pittman/docs/pfizerstatement.html

Others who continue to deny the risks posed by SSRI antidepressants are primarily stakeholders in the psychotropic drug industry who are financially indebted to these drugs’ manufacturers. First among the deniers of the scientific evidence, marching in step with Pfizer and the other SSRI drug manufacturers, is the American Psychiatric Associaion whose position has undermined its professional credibility.

Contact: Vera Hassner Sharav

Did Zoloft make him do it?
Attorneys for boy on trial argue that he committed manslaughter
By Elaine Cassel
FindLaw Columnist
Special to CNN.com
Monday, February 7, 2005 Posted: 2:23 PM EST (1923 GMT)

When he was 12 years old, Christopher Pittman killed his beloved grandparents — first shooting them with a shotgun, and then setting the house on fire, as he fled. Afterward, Pittman confessed to the crimes.

A few weeks before the killings, Pittman, who suffered from depression, had run away from his parents’ Florida home. When found, he was committed to a psychiatric institution. Doctors there prescribed medication – the powerful antidepressant Zoloft.

Pittman says that, when he committed the crime, he was hearing voices that told him to kill his grandparents.

He also reportedly said that beforehand, he had been locked in his room and, when he tried to leave, beaten by his grandfather. (His grandparents were said to have been considering returning him to his parents, due to their inability to control the boy’s behavior.)

His defense attorneys maintain that, due to the Zoloft he was taking, Pittman was involuntarily intoxicated, and that he committed manslaughter, not murder.

Now, at 15 years old, Pittman is being tried as an adult for murder in Charleston, South Carolina. Prosecutors are not seeking the death penalty; the Supreme Court has not approved executing a person who was so young when the crime occurred. But if convicted, Pittman could face a term of life imprisonment in an adult facility — possibly, but not certainly, segregated from the adults there.

Will Pittman’s claim that the influence of Zoloft made his crime manslaughter, rather than murder, prevail? In this column, I will discuss the troubling evidence on Zoloft, but I will also note that it may be difficult, nonetheless, for the defense to prevail in persuading a jury that Pittman should be convicted of manslaughter, not murder.

Zoloft and children

Zoloft, like several popular antidepressant medications, has never been specifically approved for use in children. (Zoloft has been approved for treating obsessive-compulsive disorder in children; Prozac, which I discuss below, has been approved for treating depression in children.)

Yet once the FDA approves a drug, it can be used for any purpose, in any population. Disturbingly that means that children aged 1 to 17, who make up 7 percent of the total U.S. population taking prescribed antidepressants, are ingesting psychoactive medications (those that affect the brain’s functioning) that, more often than not, have not been clinically tested for efficacy and safety in children.

A 1997 federal law, the FDA Modernization Act, attempted to encourage that drug be tested for children, in particular, but turned out to have loopholes that meant it did not serve its purpose effectively. In an attempt to remedy this problem, a 2002 federal law, the Best Pharmaceuticals for Children Act, gave the FDA the authority to order post-approval testing, for children, of drugs widely used in children. However, the FDA has yet to demand that the very antidepressants and stimulants that are so widely used in children be subjected to post-approval testing for children.

Of course, subjecting children to clinical trials brings its own set of legal and ethical dilemmas. Could parents legitimately offer their children for drug testing without the child’s consent? Could their children sue them at a later time if they suffered adverse affects from the clinical trials? Perhaps the safest alternative is to require the consent of both parent (or guardian) and child for testing.

Reasonable minds can differ as to what safeguards ought to be taken. However, one thing is clear: The current situation – in which children take drugs, tested only on adults, that may pose unacceptable dangers to them – cannot continue.

We do a terrible wrong to our children when we allow them to use untested drugs that may cause them to do violence to others, or to themselves.

Zoloft on trial

What about Zoloft, in particular? Is it dangerous for children? Precisely because studies involving children are not required before a drug can be used in children, we simply don’t know for sure.

Pfizer, the maker of Zoloft, denies that the drug causes delusions, hallucinations, or triggers violence. Responding to the defense strategy in the Pittman case, Pfizer issued a public statement rejecting the crime’s connection to its popular antidepressant. (The statement, notably, does not mention specific concerns about the drug’s effect on children.)

But anecdotal evidence, at least, suggests otherwise — as do some studies.

In 2000, studies emerged showing a possible link between hallucinations and aggression in children and teens taking Zoloft, Paxil, and Prozac. (Moreover, Pittman’s attorneys plan to introduce at trial internal Pfizer documents that, they say, show that the manufacturer knew of the possible side effects 20 years ago).

The reports were mostly linked to suicidal, not homicidal behavior. However, an attempt to link these drugs to violence against others is not without precedent. Parents of one of the Columbine, Colorado school killers unsuccessfully sued the makers of another popular antidepressant medication, Paxil, arguing that it was, at least in part, responsible for the homicidal acts of their son.

Paxil works on the brain in the same way as Zoloft and the other popular antidepressants, inhibiting the brain cell’s reuptake of serotonin from the synaptic neurons. Hence, the acronym used to refer to these drugs collectively: They are known as SSRIs, selective serotonin reuptake inhibitors. The drugs enhance the effect of the brain’s naturally occurring serotonin, a neurotransmitter that acts as a mood stabilizer.

Just why the drugs might cause hallucinations, delusions, and suicidal (and perhaps homicidal) ideation in young people, as opposed to adults, is not clear, though it might have something to do with the immaturity of the circuitry of the young brain.

In 2004, the FDA heard testimony from members of the public, the drug industry, and the medical profession regarding the use of Zoloft in children. One of the parents speaking out against Zoloft was Pittman’s father.

After the hearings, the FDA stopped short of making a finding that the drugs did cause the complained-of side effects. But it did urge the makers of the drugs to put a so-called “black box” warning on the packages, advising doctors and parents to look for signs of aggression, anxiety, and agitation in children and teens taking these medications.

Pittman’s defense: Involuntary intoxication

In a variation on an insanity defense, Pittman’s legal team is claiming that Pittman’s ingestion of prescribed Zoloft caused him to become involuntarily intoxicated on the drug. Involuntary intoxication diminishes criminal responsibility, on the simple ground that the defendant — intoxicated, but not by his own choice or consent — is not wholly at fault for crimes committed while he is intoxicated.

In their brief, the attorneys argue that this involuntary intoxication mitigates the malice aforethought required to convict Pittman of first-degree murder. But it’s possible the defense will not succeed.

For one thing, as I discussed above, although the FDA-mandated warnings mention aggression as a possible side effect, Zoloft is generally linked to instances of suicide, not homicide, and that weakens the defense.

For another thing, prosecutors have said that when Pittman confessed to the crimes, he was lucid and clear in his statements — not hazy or intoxicated-seeming. On the other hand, childhood confessions should be examined with a higher level of scrutiny.

In addition, because Pittman tried to cover up the crime through arson, and fled, jurors may believe he had enough presence of mind that he was not intoxicated in the sense that most people use the term.

Legally, however, intoxication is not equivalent to drunkenness: It simply means that the defendant is under the influence of a substance he did not willingly take (perhaps by being duped into drinking something that contained an undisclosed intoxicant), or in this case, that he did willingly take, under doctor’s orders, but without the benefit of the warning of possible violence-inducing side effects.

Perhaps the judge, in instructing the jury, will make clear that to be legally intoxicated for these purposes, one need not be, or seem, drunk. But even if the judge does so, the jury may find it hard to reconcile prosecutors’ reports of Pittman’s lucidity with the defense’s claim of intoxication.

Worsening Pittman’s chances is the fact that the jury will see before them a relatively healthy adolescent, not the mentally ill child that committed the crime. They may find it difficult — even impossible — to see before them that deranged child, rather than the 15-year-old sitting at the defense table. But it is that child, not the more mature –and presumably more mentally healthy — young man, who is on trial.

This is a dilemma facing all defendants who mount a defense based on mental illness, insanity, or diminished capacity. Since such defendants have to be competent to stand trial — that is, to be well enough to understand the proceedings and assist their attorney — they have often been treated (mainly, medicated) in order to make them coherent enough to face their accusers. Pittman’s challenge is compounded by the passage of years in which he grew from boy to young man.

A potentially tragic example

As noted above, Pittman now faces possible life imprisonment — based on what he did as a mentally ill 12-year-old. This is the result of prosecutors’ decision to charge him with murder, when manslaughter would have been more appropriate, and also of his being tried as an adult, even at the age of fifteen. (Had he been tried and convicted as a juvenile, his maximum punishment would have been limited to incarceration until he reached the age of 21.)

We need to rethink our eagerness to try children as adults in general — and more particularly in a case like this one. For when the offense was committed at a very young age, and under the influence of psychotropic medication — one associated with dangerous side effects that allegedly were known to the maker of the drug, but not disclosed to the medical profession or the public — the trial of a child as an adult, with the corresponding high penalties, is especially inappropriate.

Thus, the Pittman case is an indictment of both our medical system and our legal system — supposedly both the world’s finest. Our medical system let a 12-year-old down when it allowed a doctor to legally prescribe for him a drug that may well have caused him to have hallucinations and delusions-including the delusion that he heard voices commanding him to commit horrific crimes. Our legal system now is letting a fifteen-year-old down by pretending that he is what he plainly is not: an adult.

This toxic combination suggests that it is not just Pittman, but society, that may be in need of a cure.

Elaine Cassel, a FindLaw columnist, practices law in Virginia and the District of Columbia and teaches law and psychology. She is the author of a textbook on criminal psychology, “Criminal Behavior”, and “The War on Civil Liberties: How Bush and Ashcroft Dismantled the Bill of Rights.” She maintains a Web site devoted to civil liberties issues, Civil Liberties Watch.

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