Globalizing Clinical Research : BIG PHARMA TRIES OUT FIRST WORLD DRUGS ON UNSUSPECTING THIRD WORLD PATIENTS

By Shah, Sonia | The Nation, July 1, 2002 | Go to article overview

Globalizing Clinical Research : BIG PHARMA TRIES OUT FIRST WORLD DRUGS ON UNSUSPECTING THIRD WORLD PATIENTS


Shah, Sonia, The Nation


By the end of July a US district court will decide whether drug giant Pfizer should stand trial in the United States for presiding over a coercive, botched 1996 experiment on Nigerian children with meningitis. In a class-action suit filed last August, thirty Nigerian families say the company violated the Nuremberg Code by forcing an unapproved, risky experiment on unwitting subjects who suffered brain damage, loss of hearing, paralysis and death as a result.

If allowed, the case will open a rare window on a business generally shrouded in FDA and Big Pharma secrecy: the global commerce in human experimentation. Over the past decade, the drug industry has quietly exported its clinical testing overseas, where oversight is slim and patients plentiful. According to a largely unnoticed Health and Human Services (HHS) report, the number of foreign investigators seeking FDA approvals increased sixteenfold between 1990 and 1999. The actual numbers are probably much higher--companies aren't required to alert the FDA before taking their research overseas, nor does the FDA track research by location after approving new drugs.

Globalizing clinical research solves the pharmaceutical paradox that while the average American brings home more than ten prescriptions a year, just one in 350 is willing to play guinea pig for new drug testing. An abundance of poor, undertreated and doctor-trusting patients in Eastern Europe, Latin America and Southeast Asia renders the quick, positive results corporate sponsors need to get new drugs approved fast. According to one review, a whopping 99 percent of controlled trials published in China bestowed positive results upon the treatment under investigation. Although the HHS report found that the "FDA cannot assure the same level of human subject protections in foreign trials as domestic ones," industry officials say that companies have little interest in bending the rules. "Occasionally things go wrong," allows Pharmaceutical Research and Manufacturers of America official Caroline Loew. But generally speaking, she says, "companies that are investing $800 million in every single drug are not going to waste money on trials that don't meet [the FDA's] exacting standards." Loew says that companies test new drugs abroad so they can sell them to needy foreign patients.

Analysts disagree. "There may be a market" in some developing countries, says Tufts University's drug-development expert Kenneth Kaitin, "but they are really interested in the United States, Europe and Japan," which dominate more than 80 percent of the global drug market. Indeed, all this foreign experimentation can hardly be counted on to develop malaria vaccines or cure multidrug-resistant TB. "The diseases that are of most interest are mainly the degenerative diseases--arthritis, obesity, heart disease--the diseases of people in the developed world," says South African bioethicist Dr. Solomon Benatar.

Just 0.3 percent of the drug industry's much-touted R&D resulted in the handful of drugs approved for tropical diseases between 1975 and 1997, despite tens of thousands of industry-sponsored clinical trials conducted around the world every year. Currently, US companies are investigating treatments for oral cancer in China, lupus in Mexico and severe short stature in Eastern Europe, among other studies--not exactly a list of the world's most pressing public health problems.

Even if Americans were willing to participate in trials, they take so many medications that they make poor lab rats anyway, clinical researchers say. To prove a new drug safe and effective, "you want patients with no other disease states and no other treatments. Then you can say relatively clearly that whatever happens to those patients is from the drug," says MDS Pharma's Simon Yaxley, whose company sells what industry PR folks call "patient recruitment solutions" in Eastern Europe, South Africa, Latin America and China. …

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 ...
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.
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

Globalizing Clinical Research : BIG PHARMA TRIES OUT FIRST WORLD DRUGS ON UNSUSPECTING THIRD WORLD PATIENTS
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?

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.