Accidental overdoses alarm military officials

By Andrew Tilghman and Brendan McGarry – Staff writers
Posted : Wednesday Jun 9, 2010 10:24:51 EDT

At least 32 soldiers and Marines assigned to their services’ most-supervised medical units for wounded troops have died of accidental prescription drug overdoses since 2007.

The 30 soldiers and two Marines overdosed while under the care of special Army Warrior Transition Units or the Marine Corps Wounded Warrior Regiment, created three years ago to tightly focus care and attention on troops suffering from severe physical and psychiatric problems as a result of combat.

Most of the troops had been prescribed “drug cocktails,” combinations of drugs including painkillers, sleeping pills, antidepressants and anti-anxiety drugs, interviews and records show. In all cases, suicide was ruled out.

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Kid Overdoses in Antipsychotic Trial Caps a History of Screwups at Pfizer

By Jim Edwards | Apr 21, 2010

The FDA’s letter to Pfizer (PFE) describing overdoses of the antipsychotic Geodon given to 13 children in clinical trials is merely the latest in a long history of controversies that have dogged the drug at virtually every stage of its existence. Among those controversies: Discredited doctors allegedly prepared research on Geodon for the FDA; Pfizer allegedly promoted the drug for unapproved uses in kids; and the company allegedly paid a non-profit mental health advocacy group to promote Geodon for kids.

Taken together, the string of incidents suggests a lack of management accountability. Like many large companies, Pfizer operates as a series of silos or divisions, with different managers for sales, marketing, R&D, and regulatory compliance. The fact that screwups have occurred across all these divisions illustrates the value of having one manager, or management team, with accountability for the entire product, from soup to nuts.

The FDA warned Pfizer that its trials of Geodon in children were improperly monitored, and that children got too much drug by mistake:

… dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.

…a Pfizer internal document dated October 3, 2007 and entitled “Safety Information on Affected Subjects” refers to the overdosing of an additional six pediatric subjects in study (b)(4) at two different sites…

The kids suffered from nervous tics and a loss of control of their limbs, among other symptoms. Pfizer said it conducts tests globally according to the highest ethical and scientific standards:

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http://industry.bnet.com/pharma/10007813/kid-overdoses-in-antipsychotic-trial-caps-a-history-of-screwups-at-pfizer/