June 21

Antidepressants – USA Today Editorial / AHRP OpEd/ WSJ Editorial Bashes Spitzer

Antidepressants – USA Today Editorial / AHRP OpEd/ WSJ Editorial Bashes Spitzer

Mon, 21 Jun 2004

The debate about antidepressants, concealment of clinical trial data, and failure to warn about a suicide risk, is reaching an ever broader public. An editorial in USA Today and an invited Op Ed by AHRP (See below) focus on these issues.

Of note, both the editorial and the accompanying Op Ed agree that there is a need for clear, unambiguous warnings – the issue is no longer in dispute.

Furthermore, USA Today editors recognize the importance of full disclosure of clinical trial data: “The debate has produced one positive result: calls that all clinical studies – positive and negative – be placed on a public registry so doctors and parents can review them.”

The Alliance for Human Research Protection is proud to have been instrumental in bringing the issues in the debate to wide public attention.

Today’s Wall Street Journal editorial, by contrast, is blind to medicine’s public responsibility. The WSJ editorial is devoted to bashing Attorney General, Eliot Spitzer, for having the audacity to file a lawsuit against GlaxoSmithKline for concealing evidence of the risks and hazards posed by the antidepressant, Paxil (Seroxat), from physicians and the public. The WSJ editorial board epitomizes self-interest business ethics, ruthlessly applying the ‘profits uber ales’ approach to medicine and perverting the right to free speech:

“Last we looked, freedom of speech included the right to stay silent. Having informed regulators about the studies it performed, Glaxo had no duty to inform doctors or patients about trials the FDA itself takes responsibility for evaluating and passing along. Moreover, it’s hardly a crime for a company to talk up its products; that’s how many consumers learn about remedies in the first place.”

See: Paxil Man http://online.wsj.com/article/0,,SB108778469067142622,00.html

Last we looked, the right to remain silent is a personal right in criminal cases, not a corporate right – especially when those corporations conduct business under a government license.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

June 21, 2004
Tragic teen suicides inspire idea that invites more

In heart-wrenching testimony before federal drug regulators last February, parent after parent related how their teens had committed suicide after taking prescription antidepressants. In one case, a father told of how his 17-year-old hanged herself after seven days on Zoloft, which her doctor had stressed was safe.

Such tragic stories have helped fuel a campaign by some patient advocacy groups to pressure the Food and Drug Administration (FDA) to ban a family of widely prescribed antidepressants for anyone under 18. They say clinical studies show increased suicidal behavior and a track record that’s no better than placebos (sugar pills) in fighting depression. British regulators banned most antidepressants for minors last December.

Banning these drugs in the USA would be a premature move that could jeopardize the health of more than a million children getting relief from the misery of depression.

Depression afflicts kids

Suicide is the third leading cause of death, after accidental injury and homicide, for those 10 to 19 years of age.

Key facts*:
520,000 suicide attempts that received medical attention.
1,883 total suicides.
1 million children on antidepressants.
10 antidepressants now carrying new warnings about possible adverse behavior changes. Known as selective serotonin reuptake inhibitors, they include Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.
* – for 2001 Source: Centers for Disease Control and Prevention, 2004

Instead, concerns raised about the drugs’ safety can be addressed through improved warning labels while more studies are conducted on their effects on children. That’s the sensible approach taken by the FDA.

The FDA says it has no proof the pills cause suicidal behavior in children. Even so, it asked drugmakers in March to add warnings to 10 widely used antidepressants that instruct parents and doctors to closely monitor behavior for such changes as increased anxiety, impulsiveness or aggression.

Evidence that antidepressants are not harmful for children include: No suicides were reported in 25 studies of more than 4,000 children taking the pills. Many incidents of self-harm initially listed as suicide-related may have been misidentified, such as children slapping or superficially cutting themselves, FDA officials said.

A 2003 World Health Organization study found that the teen suicide rate dropped in 15 nations by 33% in the past 15 years, coinciding with the widespread use of the antidepressants. In the USA, the suicide rate among adolescents dropped 25% during the past decade, the Centers for Disease Control and Prevention reported June 11.

The American Academy of Child and Adolescent Psychiatry says the benefits of the pills outweigh the risks, and that links to suicidal behavior haven’t been established.

The debate has produced one positive result: calls that all clinical studies – positive and negative – be placed on a public registry so doctors and parents can review them. The American Medical Association endorsed the concept last week. That followed a suit filed June 2 by New York’s attorney general against GlaxoSmithKline, manufacturer of the antidepressant Paxil, for allegedly suppressing negative results from studies on the drug’s impact on children. Glaxo says it provided all studies to the FDA.

Supporters of a ban say evidence of the harmful effects these antidepressants have on minors is convincing. But they ignore the significant drop in the suicide rate since the medicine has been prescribed for children.

More studies focused on children will help the FDA reach a definitive conclusion. In the meantime, tougher warnings can help avert future tragedies.

Without more persuasive evidence of harm, banning antidepressants outright for children could leave too many anguished kids in the grip of debilitating depression.

Drugs’ risks too great
By Vera Hassner Sharav

Medicine’s foremost ethical principle is “First, do no harm.” When reasonable evidence exists that some children may be harmed from drugs prescribed for non-life-threatening conditions, it is our duty – and the Food and Drug Administration’s (FDA) responsibility – to protect them from preventable harm.

Published trials are the basis of treatment guidelines. But drug manufacturers and their collaborators have published false claims about the safety and benefit of antidepressants for children, by excluding negative data, thereby misleading physicians and parents. New York State Attorney General Eliot Spitzer has charged concealment of harmful data and fraud. That data, euphemistically labeled, “emotional liability,” confirm case reports of aggression, hostility and suicidal thinking and behavior in some children prescribed an antidepressant – even for a short time.

Under pressure, GlaxoSmithKline has posted previously concealed documents on its Web site. They reveal that in a clinical trial whose published report claimed Paxil was “safe and effective,” 8% of children taking Paxil became hostile compared with 0% on a placebo, and 7% became suicidal compared with 1% on a placebo. Furthermore, “worsening of depression, including suicidal ideation/gestures and hostility were the most commonly reported severe events.”

According to an FDA review of Prozac data, published reports failed to disclose that at least three children on Prozac attempted suicide vs. one on a placebo, and others were hospitalized “for suicidal ideation”; some children’s growth decreased within 19 weeks of taking Prozac; and “mania and hypomania appear to be much more common in these trials than has been the case in adult clinical studies.”

Had FDA officials wanted to protect children they would have analyzed the data long ago and issued warnings. Instead, they suppressed an FDA expert analyst’s report – which has led to a congressional investigation. They transferred data summaries to a Columbia University panel of questionable objectivity, given its close ties to drugmakers. This effort to second-guess psychiatrists who conducted the trials, evaluated children’s behavior before and after exposure to these drugs and judged their behavior to be suicidal is an exercise in futility.

Vera Hassner Sharav is president of Alliance for Human Research Protection.

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