What is FDA's Safety Standard?

To appreciate the growing challenge that bloggers pose for the press, one needs to examine medical news reports in both.

Compare the coverage of a major report in the Archives of Internal Medicine analyzing adverse events reported to FDA's Medwatch between 1998-2005. [1] [Link]

The number of serious adverse event reports went from 34,966 in 1998, to 89,842 in 2005. The number of fatal adverse drug events increased nearly 300 percent from 5,519 in 1998, to 15,107 in 2005. Reported serious events increased 4 times faster than the total number of outpatient prescriptions during the period. The authors note that the increase was influenced by relatively few drugs: 298 of the 1489 drugs identified (20%) accounted for 407 394 of the 467 809 events (87%).

These findings confirm FDA's failure to protect the public from lethal drugs--both by approving drugs whose safety has not been demonstrated, and by failing to take action when a drug is identified as killing Americans. "The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs."

Of greatest importance for consumers and physicians who prescribed unsafe drugs is to identify them. Table 4 lists the 15 drugs most frequently identified in fatal events and 15 drugs identified most frequently with serious non-fatal events. Below, the 15 drugs with the most fatalities:

IDENTIFIED DEATHS

• Oxycondone -- 5,548 (opiate)
• Fentanyl -- 3,545 (opiate)
• Clozapine -- 3,277 (antipsychotic)
• Morphine -- 1,616 (opiate)
• Acetaminophen -- 1,393 (analgesiac)
• Methadone -- 1,258 (opiate)
• Infliximab -- 1,228 (antirheumatism)
• Interferon beta -- 1,178 (immunomoderator)
• Risperdone -- 1,093 (antipsychotic)
• Etanercept -- 1,034 (antirheumatism)
• Paclitaxel -- 1,033 (antineoplastic)
• Olanzapine -- 1,005 (antipsychotic)
• Rofecoxib -- 932 (antiinflammatory)
• Paroxetine -- 850 (antidepressant)

Of note, there were fewer deaths reported involving the anti- inflammatory drug Vioxx (rofecoxib) than were reported for the antipsychotics--clozapine (Clozaril), risperidone (Risperdal) and olanzapine (Zyprexa). FDA received 932 death reports involving Vioxx, 3,277 death reports involving Clozaril, 1,093 death reports involving Risperdal, and 1,005 death reports involving Zyprexa.

Yet, Vioxx was withdrawn from the market because it was harmful to patients, while the antipsychotics--whose reported death toll far surpasses Vioxx, remain on the market. Not only that, but FDA officials have actually approved Risperdal and Zyprexa for use in children--in the latter case, overruling the team of safety officers. [Link] [Link] [Link]

One of the best blogs focusing exclusively on mental health news is [Furious Seasons (www.furiousseasons.com)]. Today's post is an example of in-depth intelligent reporting about the significance of a disturbing trend documented in FDA's database. The significance of thousands of Americans dying from adverse drug effects appears to have eluded the general press. [Link]

Furious Seasons is managed by an investigative journalist, Phillip Dowdy, whose website provides easy access to the secret Eli Lilly Zyprexa documents. Others, among them, AHRP, are constrained by the court from even providing a direct link to those documents.

Reference

1. Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005 Thomas J. Moore, AB; Michael R. Cohen, RPh, MS, ScD; Curt D. Furberg, MD, PhD Arch Intern Med. 2007;167:1752-1759. [Link]

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