Archive for the ‘Inflammatory Bowel Disease’ category

Let Patient Safety Guide FTC Decisions on Biosimilar Naming

February 4th, 2014

Today the Federal Trade Commission is conducting an workshop to determine, in part, if follow-on versions of biologic medications will have the same name as the original versions of the medications or if they will be designated by a distinguishable name or code so if there is an adverse event the doctors, patients, and regulatory agencies can track back and find the responsible product.  They would still be on the market, still be (presumably) at a lower cost, but just not able to hide.  What do you think?

Below is a link to my views in a conversation with  former Asst. Commission of FDA, Peter Pitts and a blog post from the Alliance for Patient Access which includes a letter signed my major patient associations.

Drugwonks Interview: http://drugwonks.com/blog/patients-are-a-virtue-but-not-at-the-ftc

Blog Post from the Alliance for Patient Access

By Brian Kennedy, Alliance for Patient Access

As a representative of an organization that advocates for greater patient access to approved therapies and appropriate clinical care, I am hopeful that when biosimilars are introduced into the U.S. market (later this year or early next), patients nationwide will have increased access to certain life-altering and life-saving treatments. It’s disappointing though that the Federal Trade Commission (FTC) is driving a discussion about market access and competition for biologics and biosimilars this week, yet they left important perspectives – namely patients, providers with experience prescribing biologics, and health system pharmacists – out of that dialogue.
While the U.S. Food and Drug Administration (FDA) – not the FTC – ultimately sets federal policy around the approvals pathway for biosimilars, any public discussion driven by a federal government agency is going to get attention; because of the FTC’s omission of these important perspectives, the Alliance for Patient Access (AfPA), along with the California Healthcare Institute (CHI) and thirteen other health advocacy organizations, signed a letter that has been submitted to the FTC and urges that patient safety and consumer protection be at the forefront of the FTC’s considerations, particularly when discussing the issue of the naming of biosimilar products.
Before approving biosimilars in the U.S., FDA will first need to establish naming policy for these products. Given the vast differences between chemical compounds and biologics – including biosimilars, the FDA should require distinguishable names for all biologic products, rather than requiring biosimilars and their innovator reference product to share the same name.
Patients across the country will be best served if distinguishable names are required for all biologics. By providing clarity of which medication is being recommended at the point of prescription, distinguishable names facilitate the process of determining the cause of an adverse effect and allowing patients and their medical teams route back to the origin of the problem. Issues that may be particular to a specific biological product may even be entirely untraceable without distinguishable names or other distinct identifiers.
Accordingly, through the way it sets naming policy, FDA can provide the best possible protection for patients, while simultaneously ensuring the highest credibility for biosimilars as they enter the marketplace.

Original Post and letter: http://www.allianceforpatientaccess.org/health-advocacy-organizations-submit-letter-ftc-regarding-biosimilars-naming-policy/

FTC Workshop  on Competitive Impacts of State Regulations and Naming Conventions Concerning Follow-on Biologics: http://www.ftc.gov/news-events/press-releases/2013/11/ftc-host-workshop-competitive-impacts-state-regulations-naming

 

Next-Generation Non-Profits: Liver Edition

November 6th, 2012

 

I cannot believe that it has been months since I posted.  It has been a whirlwind since July 30th when I started as President & CEO of the American Liver Foundation.  I have traveled almost 15,000 miles learning and listening to staff and volunteers in our 16 chapters around the country so that I can do the best job possible on behalf of the 30 million people in the U.S. ( like me) affected by liver disease.  During one of those trips I also had the privilege of doing an Ignite presentation at the Stanford Medicine X Conference as an e-patient scholar.  Thank you, Stanford Medicine X planners, for inviting and integrating 35 e-patients rather than the customary 1 or 2 at most meetings.

Top of mind for me was and is, what does a Next-Generation Non-Profit look like?  How do you create one?  How do you transform a last-generation traditional non-profit into one?  Thank you to Sarah Krug, Executive Director of Cancer 101 and President of the Society for Participatory Medicine for sparking many of these discussions.

Since this was a tech-y, design type crowd I kept my slides to a single number and spoke from there. Next Generation Non-Profits in Numbers_cryer

Here are my numbers decoded.

10, 792 = Days since my initial diagnosis with ulcerative colitis. 10, 792 days ago I became a patient.

18 = years since my liver transplant.   I consider myself blessed to receive this gift of life.

16,036 = number of people on the waiting list for liver transplants.  Only about 6,000 people receive transplants each year.

100 = types of liver disease. Babies are born with genetic/metabolic disorders, teenagers can develop autoimmune conditions, the CDC recommends every Baby Boomer be tested for Hepatitis C

25,000,000 = people living with at least one chronic condition.  This is not a liver-specific quandry.

11, 473 = Twitter followers of @epatientDave ( on that date) — one  measure of online patient advocacy.   Note the large gap between the number of patients and the number of epatients.  I see opportunity there.

42 = Patient advocacy groups that meet the standards of the National Health Council, the umbrella group for traditional nonprofit organizations from the American Heart Association and the American Cancer Society, and a leader in policy around chronic disease and medical research

5 = minutes, less now, to make the argument that uniting the energy of epatients with the structure and reach of the traditional patient advocacy organization we can do a better job of creating patient-defined and patient-driven change in healthcare

36= The American Liver Foundation, my organization, is 36 years old. The oldest and largest patient advocacy organization in the liver space.

1 = I am the first patient to be CEO of the Foundation and one of the only patients to lead a major patient advocacy organization (Take a moment. Think about it.)

2= questions comprise the new strategic filter for everything we do as the Foundation — (1) does it solve a problem for a patient or a patient family?  (2) are we solving the problem in the most innovative and effective way possible?

20 = number of Board members I needed to convince that these were the right questions to be asking, the right direction to go in.  And just to explode any misconceptions that next-generation non-profits is about age, or even the sole province of patients, my biggest supporter has been practicing medicine as literally as long as I have been alive.  Next-generation non-profits are about impact.

8 = active partnerships between the Foundation and other associations

14 = pilots pending with academic medical institutions

3 = satellite sites for the patient-centered advocacy forum we held to get insights directly from patients to form the basis of our policy agenda

4 = government or quasi-governmental agencies ( pop quiz — name them in the comment section!) with new (past 2-3 years) patient/stakeholder engagement positions that we invited to the forum to interact with our patients

82 = corporate partnerships being pursued across sectors from food (fatty liver disease) to medical imaging to pharmaceutical

16 = chapters around the country, because at the end of the day it is about meeting individual needs, often face to face, or based on the specifics of the community

10, 792 = days from now I hope that there is no American Liver Foundation because we would have been so successful in eliminating liver disease.  My vision is that next-generation nonprofits are not about their own self-perpetuation, but about meeting their mission. I hope that 10, 792 days from now no one else’s little girl becomes a patient.

 

 

Launch of American Liver Foundation Innovation Council Today

June 8th, 2012

Good morning, Chicago!  Looks like a great day to start something new.

Today is the launch of the American Liver Foundation’s Innovation Council.  (@ALF_USA) Chaired by Dr. Danny Sands (@Dzsands) (@S4PM), Director of Healthcare Business Transformation at Cisco, and Dr. Nancy Reau, Assistant Professor of Medicine at the University of Chicago, the ALF Innovation Council is intended to bring together creative minds from across silos in healthcare to help us solve key problems facing liver disease patients and their families.

The program will also feature a panel of patients discussing their various experiences with liver disease and a presentation of the state of liver disease and treatment today.

If you are reading this blog post, it is likely that you have been unable to join us in person, but we’d still love your input.

Please comment on the four questions below or tweet us this afternoon (we start at 1pm CT) using the hashtag #ALF_IC.    Many thanks to the Innovator companies who are helping to spark our imaginations.

Step One: Detection/Diagnosis : Moderator Nancy Reau, MD

Key Issue/Question: How can we expand the number of patients in rural and underserved communities accurately diagnosed with liver disease?

Innovation Example: OraSure Rapid Test (rapid diagnostic test for HIV and HCV) @OraSureTech

 

Step Two: Newly Diagnosed/Treatment Selection: Moderator Danny Sands, MD

Key Issue/Question: How can we accelerate the understanding of a patient and their family of their diagnosed condition and how they are going to navigate an increasingly complex set of options?

Innovation Example: Inquisit Health (peer-to-peer web platform) @InquisitHealth

 

Step Three: In-Treatment: Moderator John Kontor, MD

Key Issue/Question: How can we optimize therapies by helping patients overcome barriers to adherence?

Innovation Example: Ginger io (smartphone/SMS/adherence and behavior feedback program)

 

Step Four: Survivorship: Donna Cryer, JD @DCpatient

Key Issue/Question: What are the best long term outcomes for liver patients and how do we achieve them?

Innovation Example: Galileo Analytics (data mining and visualization tool)