Skip to main content

Main menu

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 articles
    • Obituary notices
  • Authors & Reviewers
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
    • Patient engagement
  • Physicians & Subscribers
    • Benefits for Canadian physicians
    • CPD Credits for CMA Members
    • Subscribe to CMAJ Print
    • Subscription prices
    • Obituary notices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2023
    • Avis de décès
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN

User menu

Search

  • Advanced search
CMAJ
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN
CMAJ

Advanced Search

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 articles
    • Obituary notices
  • Authors & Reviewers
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
    • Patient engagement
  • Physicians & Subscribers
    • Benefits for Canadian physicians
    • CPD Credits for CMA Members
    • Subscribe to CMAJ Print
    • Subscription prices
    • Obituary notices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2023
    • Avis de décès
  • Visit CMAJ on Facebook
  • Follow CMAJ on Twitter
  • Follow CMAJ on Instagram
  • Listen to CMAJ podcasts
Features

Making a case for a $2700-a-month drug

Barbara Sibbald
CMAJ November 02, 1999 161 (9) 1173;
Barbara Sibbald
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Responses
  • Metrics
  • PDF
Loading

A new class of biotherapeutic cancer drugs costs $2700 a month but its proponents make no apologies. Trastuzumab (Herceptin), the first monoclonal antibody approved for use in Canada, adds an average of 5 months to the lives of up to a third of women with metastatic breast cancer. And although the price has raised ethical questions about whether people have a right to a therapy regardless of its cost, those involved say it's not exorbitant given the expense of development and production.

Neil Cohen, a spokesman for the drug's manufacturer, California-based Genentech, Inc., says the high cost is due to the years of research and development - including a phase 3 clinical trial involving 900 patients - manufacturing costs and ongoing research into other possible uses.

Dr. Brian Leyland-Jones, a lead investigator for the trastuzumab clinical trials, says it costs between $250 and $500 million to bring a regular pharmaceutical product to market. "The costs are phenomenal," he argues. He is presently involved in another trial in which the drugs needed for 8 patients cost $250 000.

Research into monoclonal antibodies has been under way for 15 to 20 years. Rituximab (Rituxan), which targets non-Hodgkin's lymphoma, entered the US market 2 years ago but is still awaiting Health Canada approval. A 22-day course of that drug costs US$9438. Trastuzumab, the second monoclonal antibody and the first gene-directed therapy, received Health Canada approval in August.

In the US, Genentech dodges the tricky ethical issues by providing trastuzumab and its other drugs free to uninsured or underinsured patients. Over the past 12 years, Genentech has given away more than $200 million worth of its drugs.

However, that's not the case in Canada, where administrators are wondering just how much the public health care system can afford. Ontario has agreed to pay for the new breast cancer drug, and BC is following suit, but other provinces haven't made a decision yet. This uncertainty will no doubt contribute to what ethicist Margaret Somerville calls a "surge" in court challenges over withholding medically necessary treatment.

Somerville, the director of the Centre for Medicine, Ethics and Law at McGill University, agrees that Canada's health care system can't pay for everything. "We can't afford to offer every treatment to everyone ... but we have always lived with the myth that we can." She says the soaring litigation is a sign that this "myth is being shattered."

But the cost shouldn't override the "huge promise" inherent in trastuzumab and this whole new family of drugs, says Leyland-Jones, professor and chair of McGill's Department of Oncology. "This is just the tip of the iceberg," he says, since other drugs based on monoclonal antibody drugs are now being developed. "They are discriminate, selective drugs aimed at specific genetic targets," he says. "It's entirely different from chemotherapy or radiation."

Side effects are negligible. Leyland-Jones says some patients report chills and fevers the day of their first infusion, but nothing more. "Patients said it's like taking water," he said. The drug is administered weekly.

Leyland-Jones says cancer therapy has been evolving since the end of the last century. The first advances were in surgery, followed by the introduction of radiation. Those developments were followed by the arrival of chemotherapy in the 1940s. This latest step is "fourth-generation therapy - the selective gene-targeted therapies."

Trastuzumab has been in the making since 1986, when American oncologist Dennis Slamon and German molecular biologist Axel Ullrich discovered that as many as 35% of breast tumours contained a mutation in the HER2 (human epidermal growth factor receptor 2) oncogene (also known as c-erbB2). This mutation causes breast cells to make abnormally high amounts of the HER2 protein (overexpression), which appears as a receptor on the surface of the cell. These receptors receive chemical signals from the body to grow, stimulating the cells to grow out of control. Ullrich and Slamon also discovered an antibody that clung to the HER2 protein, marking the cancer cells for death. Genentech owns the rights to the antibody.

The drug was extensively tested in a 4-arm study: trastuzumab alone; trastuzumab with the chemotherapy combination doxorubicin and cyclophosphamide; trastuzumab with chemotherapy including paclitaxel (Taxol); and paclitaxel alone. The women taking trastuzumab combined with doxorubicin and cyclophosphamide had an increased (27%) risk of cardiac dysfunction, including impaired left ventricular function and heart failure. However, trastuzumab combined with chemotherapy including paclitaxel was found to improve survival by an average of 5 months over chemotherapy alone in women with metastatic breast cancer and overexpression of the HER2 protein.

PreviousNext
Back to top

In this issue

CMAJ
Vol. 161, Issue 9
2 Nov 1999
  • Table of Contents
  • Index by author

Article tools

Respond to this article
Print
Download PDF
Article Alerts
To sign up for email alerts or to access your current email alerts, enter your email address below:
Email Article

Thank you for your interest in spreading the word on CMAJ.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Making a case for a $2700-a-month drug
(Your Name) has sent you a message from CMAJ
(Your Name) thought you would like to see the CMAJ web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Making a case for a $2700-a-month drug
Barbara Sibbald
CMAJ Nov 1999, 161 (9) 1173;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
‍ Request Permissions
Share
Making a case for a $2700-a-month drug
Barbara Sibbald
CMAJ Nov 1999, 161 (9) 1173;
Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like

Jump to section

  • Article
  • Responses
  • Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • The link between publicly funded health care and compulsory licensing
  • Google Scholar

More in this TOC Section

  • Staffing crisis looms, radiologists warn
  • Ball rolling on research into heading injuries
  • MDs sceptical as BC gives stamp of approval to traditional Chinese medicine
Show more Features

Similar Articles

 

View Latest Classified Ads

Content

  • Current issue
  • Past issues
  • Collections
  • Sections
  • Blog
  • Podcasts
  • Alerts
  • RSS
  • Early releases

Information for

  • Advertisers
  • Authors
  • Reviewers
  • CMA Members
  • CPD credits
  • Media
  • Reprint requests
  • Subscribers

About

  • General Information
  • Journal staff
  • Editorial Board
  • Advisory Panels
  • Governance Council
  • Journal Oversight
  • Careers
  • Contact
  • Copyright and Permissions
CMAJ Group

Copyright 2023, CMA Impact Inc. or its licensors. All rights reserved. ISSN 1488-2329 (e) 0820-3946 (p)

All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association or its subsidiaries.

To receive any of these resources in an accessible format, please contact us at CMAJ Group, 500-1410 Blair Towers Place, Ottawa ON, K1J 9B9; p: 1-888-855-2555; e: [email protected]

CMA Civility, Accessibility, Privacy

 

Powered by HighWire