Chapter  7: Human Experimentation

Section 5. Case Study

By: Jon Shobin

Case Title: Experimental Drug Erbitux

Description:

ImClone, a biotech company, was a high-flying Wall Street darling until recently. One of the most interesting products in its pipeline was an experimental drug initially called C-225, later renamed Erbitux. Erbitux is a monoclonal antibody that shows great promise in cancer therapy. Normally, Phase I-III FDA clinical trials take considerable time. However, Erbitux showed so much promise in the preliminary trials that it was given what is called ?fast track? status. As word of Erbitux?s success spread through the cancer community, more and more patients ? some of whom were desperate because they?d already undergone traditional therapies ? petitioned ImClone for the drug. Experimental drugs are sometimes given to non-trial patients under what is called ?compassionate use.? Exactly who got the drug, under what circumstances, and who didn?t was and is the subject of much ethical controversy.

URLs for articles describing the case : www.das.journal/View173741/N/11736385

this is a scientific article discussing the effectiveness of C-225 in mouse bladder cancers

www.das.journal.view/1737413/N/134961?source=MI

Another scientific article about the interactions of ImClone?s endothelial growth factors. Originally in J.Biol. Chem, 12 May 2000.

www.imclone.com ? The company?s website which includes clinical trial information, to date, on Erbitux.

www.ccalliance.org/news

 An article about ImClone?s recent setback in its attempt for FDA licensure.

URLs for articles with ethical positions:

www.house.gov/ -- go to Committee on Energy and Commerce ? Ethical and other questions pertaining to Erbitux in 2001 by the House Committee on Energy and Commerce

www.aol.com, keyword Web Md. An ethical editorial by Jeff Levine on how ?Dying Patients Find Experimental Drugs Hard to Get.?

www.cbsnews.com, on ?60 Minutes? ? A dying woman?s story, along with ethical commentary, about struggling to get Erbitux through the compassionate use route.

Two further sources for commentary on ethics and Erbitux:

www.icflorida.com/partners

www.businessweekonline.com

 

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Copyright Philip A. Pecorino 2002. All Rights reserved.

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