Who We Are - What We Are Doing - What You Can Do



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I. Who we are

We are "People with Bleeding Disorders and HCV"
We are patients and supporters affected by the HCV crisis among people with bleeding disorders.
We organize and lobby for development and availability of new, far better, HCV therapies.


II. Public Positions (most recent first)
.
Letter to Gilead Sciences 
Letter of August 28, 2012 to Gilead Sciences requesting that steps be taken to respond to our immediate and desperate need for better HCV therapies 
March 2012 Update and Request for Comment
Plans: 
Next Push, Advanced Therapy
(November 28, 2011)
Dr. Janet Woodcock of FDA names contact for expanded access (response to our letter of May 25)
Letter to Dr. Margaret Hamburg, FDA Commissioner, requesting assistance for curative HCV drug trials, dated May 25, 2011
National Hemophilia Foundation recommendations for treatment of chronic HCV in people with bleeding disorders, dated May 22, 2011
We recommend approval of Telaprevir and Boceprevir at FDA hearings on April 27 and 28, 2011

Formal Comments on FDA Draft Guidance for testing Drug Combinations (Submitted Feb 14, 2011)



III. Publicity

"Blood Brothers in Action" (article in HFA Dateline - Summer 2012, page 20)
NHF Hemaware Winter 2011  "Access to Hepatitis C Clinical Trials - Feb 2011"
New York Times article 7/22/2010, particularly see last Paragraph
Most 2010 and 2011 Issues of HCV/HIV Today (load home page and then click on resources)
Hemophilia Federation of America: "Community Members Take Action"



IV
. Communications to "People with Bleeding Disorders and HCV"

Update of Feb 17, 2013 (Announces Petition to Whitehouse)
Update of Feb 14, 2013 (AIDS Healthcare Foundation supports petition to Gilead)
Update of November, 2012
Agenda, Roundtable on Hemophilia and HCV,  and Presentation by People with Bleeding Disorders and HCV (October 17, 2011)
Report on Activities (October 6, 2011)
Proof of Concept for Direct Acting Antivirals to Cure HCV (March 27, 2011)
The Worst Drug in History (Feb 11, 2011)
Our positive take on FDA Draft Guidance for testing drugs combinations (Final to FDA in Feb 2011)
Report on FDA Hearing of April 30, 2010
Thoughts on the FDA Response to the Citizens' Petition


V. What You Can Do to Help Obtain Access to Promising HCV Therapies for Our Community

See letter to our letter to Gilead Sciences, a pharmaceutical firm, co-signed by the Hemophilia Federation of America, The Committee of Ten Thousand, and People with Bleeding Disorders and HCV.  

In summary, we

 request that Gilead Sciences take the following steps to respond to our immediate and desperate need for better HCV therapies:

1. Change their current drug development model which prevents testing of Gilead-owned investigational drugs in combination with ‘best of class’ investigational drugs owned by other companies, and

2. Include people with bleeding disorders in clinical trials, and

3. Ensure that their best investigational drugs are available for compassionate access by our community.


Here's the background:

This spring, pharmaceutical developers Gilead Sciences and Bristol-Myers Squibb (BMS) reported a small collaborative study utilizing one investigational drug from each company ... to achieve startlingly high levels of HCV cure with low side effects.   Many of you are aware that one of the companies, Gilead, has withdrawn from any further studies with this combination, preferring instead to develop drug combinations in-house.  Journalists who cover drug development have generally concluded that the Gilead decision will slow down drug development, and that it derives from business concerns rather than from patient concerns.  Consistent with that analysis, we’ve seen little indication that Gilead will rush drug access to the many people in our community threatened by advanced disease and poor medical options. 


On a positive note, our community is not alone!  A substantial group of HCV patients and supporters are promoting a petition to Gilead sciences asking that they rethink their stance on drug development.  Here’s a link to that effort:        

http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now

We encourage our friends and supporters to CIRCULATE and SIGN THE PETITION TO GILEAD SCIENCES


Mark Antell and Paul Brayshaw, for

People with Bleeding Disorders and HCV


2. Support your local and national Bleeding Disorders organizations!  Together we can have a voice in setting health delivery policy.

 
The three national hemophilia organizations are:
- Hemophilia Federation of America (HFA): www.hemophiliafed.org
- National Hemophilia Foundation (NHF): www.hemophilia.org
- Committee of Ten Thousand (COTT): www.cott1.org
NHF and HFA have local affiliates and offices. 

NHF and HFA cosponsored the Citizen Petition to FDA of 2010.
HFA and COTT have joined in sponsoring the letter to Gilead of 2012. 


3. Finally, suggestions are welcome and any added efforts greatly appreciated.    

Mark Antell
Paul Brayshaw

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