Physicians Don't Wait for the FDA to Act: Aspirin Makers Hail New Decision

By Goldreich, Samuel | The Washington Times (Washington, DC), January 24, 1997 | Go to article overview

Physicians Don't Wait for the FDA to Act: Aspirin Makers Hail New Decision


Goldreich, Samuel, The Washington Times (Washington, DC)


Washington obstetrician Dr. Bruce Bonn makes a regular habit of ignoring the Food and Drug Administration in prescribing drugs for his patients.

While the federal agency fields an army of bureaucrats and professional advisory panels to approve new drugs and new uses for existing pharmaceuticals, Dr. Bonn regularly recommends birth control pills for purposes that have not been approved.

Like doctors across the nation, Dr. Bonn routinely practices medicine without waiting for the FDA to catch up with the latest scientific developments. And it's perfectly legal.

That paradox was underscored yesterday when an FDA advisory panel recommended allowing aspirin makers to label their product for use in the prevention of heart attack and stroke. Although aspirin makers have been allowed to market the drug as a treatment for patients in risk of a second stroke as long ago as 1980, they could not tout many of the other benefits of the drug's blood-thinning properties.

Likewise, while Dr. Bonn is free to tell his patients about all the benefits of the birth control pill, its manufacturers are allowed only to market it according to the limitations cited in FDA-approved labels. In fact, FDA regulations prohibit drug companies from touting their products' unapproved uses to doctors unless they receive a specific request for information.

"The use of oral contraceptives for their non-contraceptive benefits - what is considered off-label uses - is very common," he says. "With the spread of AIDS and other [sexually transmitted diseases], people should be using condoms for the most part. Now, we are actually using birth control pills for their non-contraceptive benefits."

Among the diseases and problems that numerous studies report the pill is useful in treating are uterine and ovarian cancer, pelvic inflammation, excessive menstrual bleeding, and cramps. But any drug firm that circulates such studies would be breaking the law.

Off-label usage is so widespread that the General Accounting Office has reported that doctors prescribe more than 50 percent of cancer drugs for treatment in cases that have not been approved by the FDA.

All that would change under a general FDA reform bill drafted by the Pharmaceutical Research and Manufacturers Association, which wants to allow manufacturers to circulate peer-reviewed medical literature that reports new drug uses.

"We should be able to disseminate such information as soon as it's available rather than wait until it is approved by the FDA," said Mark Grayson, a spokesman for drug trade group.

A similar off-label reform bill failed last year, but Republicans have vowed to make it a priority as part of FDA reform this year.

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

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

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 ...
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.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

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 article

Physicians Don't Wait for the FDA to Act: Aspirin Makers Hail New Decision
Settings

Settings

Typeface
Text size Smaller Larger
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?

Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now 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

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

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.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.