By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    healthcare cybersecurity
    4 Helpful Tips on How to Protect Your Medical Practice Against Cyber Attacks
    October 24, 2021
    Health Check Diagnosis Medical Condition Analysis Concept
    6 Health Woes With Online Remedies
    January 19, 2022
    Eight Things Men Should Know About the Male Menopause
    Eight Things Men Should Know About the Male Menopause
    April 24, 2022
    Latest News
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
    The Best Home Remedies for Migraines
    June 5, 2025
    The Hidden Impact Of Stress On Your Body’s Alignment And Balance
    May 22, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Vermont Gov. Signs Single Payer Bill into Law
    May 26, 2011
    Pharma R & D Spending is Down
    July 2, 2011
    Healthcare Spend at Historic Low
    August 8, 2011
    Latest News
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 2025
    Top HIPAA-Compliant Messaging Apps for Healthcare Teams
    June 25, 2025
    When Healthcare Ends, the Legal Process Begins: What Families Should Know About Probate and Medical Estates
    June 20, 2025
    Preventing Contamination In Healthcare Facilities Starts With Hygiene
    June 15, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: The Battle Over Avastin
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Business > The Battle Over Avastin
Business

The Battle Over Avastin

Archelle Georgiou
Archelle Georgiou
Share
4 Min Read
SHARE

The use of Avastin for breast cancer was addressed by the U.S. Food and Drug Administration this week. The outcome was devastating for Roche and an emotional one for many women who believe the FDA is subjecting them to a death sentence.  As usual, there are a variety of perspectives to take into consideration.

The history: In 2008, Avastin was given preliminary approval by the FDA for the treatment of breast cancer on the condition that the company would do more studies to demonstrate its effectiveness. Many women have been successfully treated with Avastin — a billion dollar drug for Roche.

But when Roche submitted the required follow-up studies in 2010, the data showed that there was no benefit from the drug for treating breast cancer.  Studies did not show significant impact on mortality or  improvement in quality of life.  In addition, the drug was associated with some significant side effects such as high blood pressure and blood clots.

In December, 2010, an FDA panel voted to withdraw the drug’s approval as a treatment for breast cancer.  Roche appealed the decision, and earlier this week, an FDA panel hearing the appeal unanimously decided, in a 6-0 vote, to withdraw the drug’s indication for breast cancer.  The final decision on whether or not Avastin loses the indication is ultimately up to the FDA Commissioner, Dr. Margaret Hamburg.

If Hamburg supports of the panel’s recommendation is critical. At the same time, this will fuel even more emotion and protests among patients. Here’s why:

• From the FDA’s side: The FDA issued a provisional approval with the explicit understanding that the final decision would be based on more conclusive studies. If the FDA maintains the drug’s approval despite the lack of scientific data, this would likely impact all of their future decisions to offer provisional approvals for potentially life-saving drugs.
• From the patients’ side: Women who have benefited from the medication have clearly voiced their opinion that the doctors and patients, not regulators, should decide whether or not to get potentially life-saving treatment.

An important fact to keep in mind is that Avastin will remain on the market because it is FDA-approved for certain types of lung, colon, kidney and brain cancers. Therefore, Avastin will still be available “off label” for treating breast cancer when patients and their doctors believe that it is the best option.  In those situations, the only real challenge will be a barrier to access is a financial one since expensive drugs used “off-label” are frequently not a covered benefit and very few women can afford to $80,000 per year out of pocket for Avastin.

Roche is understandably passionate about making this drug available to women, and they will be pursuing additional studies to prove its effectiveness.  But, in the mean time, there is a solution that’s not been discussed and doesn’t involve beating up on insurance companies: For women who decide (despite the data) that they want or need Avastin, Roche could simply decrease the cost.

What do you think?

Create Health,
Archelle

Sources:
FDA begins process to remove breast cancer indication from Avastin label
www.fda.gov/newsevents/newsroom/pressannouncements/ucm237172.htm

A version of this blog was originally posted on EmpowHER.

TAGGED:AvastinFDAhealthcare businesshealthcare law
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

9 Lifestyle Tweaks That Can Add Years to Your Life
9 Healthcare Lifestyle Tweaks That can Add Years to Your Life
lifestyle
July 11, 2025
car accident lawsuit
Let Your Lawyer Handle the Work Before You Pay Medical Costs
Policy & Law
July 6, 2025
women dental care
What Is a Smile Makeover and How Much Does It Cost?
Dental health
June 30, 2025
HIPAA-Compliant Messaging Apps
Top HIPAA-Compliant Messaging Apps for Healthcare Teams
Global Healthcare Policy & Law Technology
June 25, 2025

You Might also Like

Bridging The Gap In Multi-Generational Medical Marketing
Business

Bridging The Gap In Multi-Generational Medical Marketing

October 18, 2017
healthcare marketing tips
Business

7 Counterintuitive Tips: Creating Content That Actually Means Something

December 4, 2013
Hospital Administration

Things To Consider Before Becoming A Locum Tenens Hospitalist

June 21, 2021
Dx Cost and patient Centeredness
BusinessDiagnosticsHospital Administration

Patient-Centered Physicians Have Lower Diagnostic Testing Costs

June 26, 2014
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?