Time to End the Tyranny: The Agency Needs to Be Removed from the Drug Evaluation Equation

By Emord, Jonathan W. | USA TODAY, February 2011 | Go to article overview

Time to End the Tyranny: The Agency Needs to Be Removed from the Drug Evaluation Equation


Emord, Jonathan W., USA TODAY


THERE have been many instances in which drug industry executives have been complicit with Food and Drug Administration political appointees in causing unsafe drugs to enter the market over the objections of FDA medical reviewers. The political angst now expressed concerning just one of the drugs, GlaxoSmithKline's Avandia, is dreadfully late--coming a decade after FDA medical reviewer Robert I. Misbin first sounded the alarm on the link between that type 2 diabetes drug and heart problems. Had Misbin been credited instead of discredited, the drug never would have entered the market if it did, would have been accompanied by extreme warnings.

The story of the approval of Avandia over the objection of agency medical reviewers (and FDA defense of the drug for more than a decade) reveals precisely why the agency cannot be counted upon to protect the American public. In an April 21 1999, internal memo, Misbin explained to his superiors his concerns "about deleterious long-term effects on the heart" from the drug. His criticisms were rejected. On May 25, 1999, FDA approved the drug for marketing without referencing the heart risks. Dr. Misbin later stated that one of his superiors said something to him that he never forgot: "We have to maintain good relations with the drug companies because they are our customers." In February 2006, another FDA medical reviewer, Rosemary Johann-Liang, strenuously urged that the FDA require GlaxoSmithKline to put a black box warning on the drug, alerting people to its effect of increasing the risk of heart attack. Dr. Johann-Liang's supervisor told her that FDA management was "upset with [her] recommendation" and "decided to act like [her] review never happened."

[ILLUSTRATION OMITTED]

Rep. Diane E. Watson (D.-Calif.) used the drug for her diabetes. She developed a heart murmur that she attributed to Avandia in a congressional hearing. On the advice of her physician, she stopped taking the drug. Seven years after the drug entered the market, caving to pressure brought on in no small measure by the efforts of FDA Office of Drug Safety Associate Director David Graham, the FDA ordered a black box warning on Avandia labeling, but kept the drug on the market. In July 2007, an FDA advisory panel voted 20-3 that Avandia increases cardiac ischemic risk in type 2 diabetics, but voted in favor of keeping the drug on the market. In other words, the economic interests of the drug industry won out over sound medical judgment.

There are many treatments for type 2 diabetes that do not entail a 43% increased risk of heart attack, yet the FDA has, until recently, been a dogged defender of this drug--seemingly unaffected by severe medical, scientific, political, and public criticism. If there was any question that the drug industry exercises undue influence over the FDA, the case of Avandia (and over a dozen unsafe drugs now on the market) should have eliminated that doubt. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Time to End the Tyranny: The Agency Needs to Be Removed from the Drug Evaluation Equation
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Author Advanced search

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.