C3 President testifies at ODAC meeting on anemia drugs

Carlea Bauman, President of C3:Colorectal Cancer Coalition, testified at the March 13 meeting of the FDA Oncologic Drugs Advisory Committee (ODAC).  Bauman called for restricting use of erythropoiesis-stimulating agents (ESAs) to a registry program where information about risks and benefits could be collected and analyzed.

Her full comments are below:

C3: Colorectal Cancer Coalition is a non-profit, nonpartisan advocacy organization committed to winning the fight against colon and rectal cancer through research, empowerment and access.

C3 believes in fully disclosing sources of financial support. In 2006 and 2007, C3 received funding from Amgen in the form of a charitable donation. Johnson & Johnson held a meeting in February 2008 in Washington, DC, and paid the travel expenses of a C3 Board member. Neither of these companies nor any of our other corporate supporters have influenced our comments on this issue.

Today, I speak on behalf of the tens of thousands of people who receive treatment for colorectal cancer each year. They believe these treatments will save or prolong their lives, and wouldn’t dream of taking something that might hurt their chances of survival. They are used to looking at complex risk/benefit situations in their treatment plans. This situation, however, includes several frustrating and concerning issues. For example:

• These drugs, which provide supportive care to patients in treatment for cancer, help patients avoid transfusion. They also increase the risk of death due to blood clots and could actually cause a patient’s cancer to grow faster.
• There is a systemic inability to find and analyze all of the relevant data – who has it, who owns it, who can see it?
• There is a perceived lack of progress. ESAs have been on the market for many years, billions of dollars have been spent by insurers, millions of patients have been treated, and yet we still have many of the same unanswered questions we had at the 2004 ODAC.
• There is mistrust of the manufacturers, the oncology professional associations and patient advocacy organizations because of potential financial conflicts of interest.

C3 believes that we are at a point where the questions outweigh the answers. Therefore, we feel it is appropriate to restrict use of these drugs to situations where data is gathered in an effort to get more answers. We believe that it will be very difficult to complete enrollment in the proposed phase 3 trial while these drugs are widely-used by oncologists. Our letter details our concerns with this proposal and with the RISK-MAP strategy proposed by the sponsors.

Thus, we suggest implementation of a registry program. FDA implemented a patient registry and informed consent process for drugs such as natalizumab and thalidomide through the Special Restricted Distribution Program. This program has enabled patients to have access to these potentially helpful, potentially harmful drugs in a controlled way which can also help inform future use of the drugs. CMS worked with several organizations to implement the National Oncologic Pet Registry which has collected information about pet scans since May 2006. Registries have strengths and limitations. We are interested to hear FDA and ODAC’s thoughts on the feasibility of a registry for ESAs.

Thank you for your consideration of our comments

The ODAC meeting was covered by the New York Times, which included Bauman’s comments in their report.

Posted by Kate Murphy on March 14th, 2008
Posted in: Research & Treatment News | No Comments »

FDA committee recommends restrictions on use of anemia drugs during chemotherapy

In a meeting on March 13, 2008 the Oncologic Drugs Advisory Committee (ODAC) of the FDA recommended further restrictions in the use of erythropoiesis-stimulating agents or ESAs to treat chemotherapy-induced anemia.  The drugs, marketed as Aranesp®, Epogen®,and Procrit®, are given to prevent blood transfusions during chemotherapy.

While the committee did not recommend completely ending prescribing ESAs for cancer patients, they did ask that use be limited:

• They voted 13 to 1 that ESAs remain available to some cancer patients.
• By a vote of 9 to 5, the panel said that ESAs should not be used by patients with breast or head and neck cancer, where evidence is strongest that the drugs may shorten survival.
• In a vote of 11 to 2, with 1 abstaining, they recommended that ESAs not be used when patients were being treated with the goal of curing their cancer but be limited to treatment of advanced stage disease.
• They urged that patient sign an informed consent before they were given ESAs helping them to understand the potential risks.

The ODAC recommendations are included in an article in the New York Times that also has statements made during the meeting by Carlea Bauman, C3:Colorectal Cancer Coalition President, and Robert Erwin, a member of the C3 Board of Directors.

Carlea Bauman, President of C3:Colorectal Cancer Coalition, told the panel,

There is a perceived lack of progress. The drugs have been on the market for many years, billions of dollars have been spent by insurers, millions of patients have been treated, and yet we still have many of the same unanswered questions.

C3 recommended establishing a registry of patients who were taking the drugs so that information could be collected and analyzed about ESA risks and benefits.

Background information on the studies that ODAC considered in preparation for yesterday’s meeting is included in an FDA Briefing Document.  From that document:

Whereas at the time of approval, safety concerns were theoretical, there is now mounting evidence of documented effects on survival, tumor progression, and thrombotic events which require a re-assessment of the net benefits of this class of drugs. With the results of two additional clinical studies with evidence of harmful effects (a total of eight studies as of this date), FDA requests the Committee’s advice with regards to appropriate actions to be taken at this time.

Prior to the meeting, Amgen who manufactures the ESA drugs under consideration issued this statement. They wrote,

Amgen strongly believes that ESAs provide an important clinical option for some patients, and looks forward to collaborating with the ODAC and FDA to maximize the benefits of these drugs when used according to the approved labeling while minimizing the risks.

The ODAC meeting was prompted by information from eight different studies that showed poorer outcomes for cancer patients who received an erythropoiesis-stimulating drug rather than a placebo to treat anemia.  There was evidence that ESAs might be responsible for poorer survival, additional blood clots, or growth of tumors.

Since the studies were exploring new uses of the drugs beyond the limits on the approved FDA label, safety issues for labeled uses were not clear.  Many questions about safe use of ESAs for cancer patients receiving chemotherapy remain.

In November of 2007, the FDA revised labeling for Procrit, Aranesp, and Epogen to reflect research that found anemic patients not on chemotherapy had reduced survival when given the drugs.  The new label included black box warnings:

• Not to target hemoglobin levels at or above 12 g/dL.
• Risks of shortened survival and tumor progression have not been excluded at target hemoglobins below 12 g/dL
• Use the lowest dose possible to avoid blood transfusion
• Use only for chemotherapy-induced anemia, not for anemia in cancer patients who are not receiving chemotherapy.
• Stop ESAs when chemotherapy ends

The March 18 ODAC recommendations must be acted on by the FDA before more labeling changes are made, but their opinions are usually taken very seriously.

What does this mean for patients?

If you are anemic and on chemotherapy, discuss using an erythropoiesis-stimulating agent (ESA) such as Procrit, Aranesp, or Epogen very carefully with your doctor.

• You should not take an ESA to treat cancer anemia if you are not on chemotherapy.  (On the FDA approved label)
• There is no evidence that an ESA will make you feel better or improve your quality of life.
• The goal of using an ESA is to reduce the risk of needing a blood transfusion, but you may still need one even if you take an ESA.
• Ask that the lowest dose possible be used to slowly raise hemoglobin levels. (On the FDA approved label)
• Stop ESAs when you stop chemotherapy.

While the latest ODAC recommendations are not yet part of the FDA labeling for Procrit, Aranesp, or Epogen, you should also discuss them with your doctor including:

• Not taking an ESA if you have breast cancer or head and neck cancer.
• Not using an ESA for cancer treatments that are focused on cure such as adjuvant treatment after surgery for cancer that has not yet spread.

ODAC has recommended that patients and doctors discuss the risks and benefits of ESA use together.  You may be asked to sign an informed consent before being treated with one.  Read it carefully, discuss it with your doctors and your family, and make your own decision.

Disclosure:  C3 believes in fully disclosing sources of financial support. In 2006 and 2007, C3 received funding from Amgen in the form of a charitable donation. Johnson & Johnson held a meeting in February 2008 in Washington, DC, and paid the travel expenses of a C3 Board member. Neither of these companies nor any of our other corporate supporters have influenced our comments on this issue.

Posted by Kate Murphy on March 14th, 2008
Posted in: Research & Treatment News | No Comments »

Breaking Boundaries Program Honors Colorectal Cancer Survivors for Outstanding Leadership Achievements

New Program Seeks to Break Down Boundaries That Can Limit Treatment Options for Older Colorectal Cancer Patients

Alexandria, VA, March 11 -– C3: Colorectal Cancer Coalition (C3) will announce today the 2008 award recipients of the Breaking Boundaries program, an initiative aimed at raising awareness of the need to break down the boundaries that can limit appropriate treatment of older colorectal cancer patients. Breaking Boundaries honors the outstanding leadership achievements of older patients who have been successfully treated for colorectal cancer and continue to serve their communities and other patients.

Three extraordinary women will be recognized for their valuable leadership contributions during the Breaking Boundaries Awards Dinner and Reception as the culmination of the C3 annual “Call-on Congress” advocacy initiative during National Colorectal Cancer Awareness Month in March. Representatives of C3 and renowned thought leader in oncology, Dr. Richard Goldberg, associate director of The Lineberger Comprehensive Cancer Center at The University of North Carolina, selected the award recipients.

As part of the C3 Call-on Congress, on Tuesday, March 11th, the three Breaking Boundaries honorees will visit their Members of Congress in their Capitol Hill offices to lobby for legislation that will guarantee access to colorectal cancer screening for millions of Americans.

“We initiated the Breaking Boundaries program as a way to showcase older colorectal cancer patients who exemplify what can be achieved when appropriately treated,” said Carlea Bauman, President, C3: Colorectal Cancer Coalition. “We are thrilled to honor older Americans who have come through colorectal cancer treatment to make a difference in their own lives and in the lives of others.”

A key objective of Breaking Boundaries is to highlight the need for older colorectal cancer patients to have equal access to the full range of treatment options, based on standard clinical factors such as tumor size and growth rate, regardless of their age.

“Colorectal cancer is primarily diagnosed in patients age 50 and over, so we need to ensure that these individuals have access to all available treatment options based on standard clinical factors such as tumor size, cancer spread to lymph nodes and tumor growth rate,” said Dr. Goldberg. “Recent research, including a study I published last year, showed that combination chemotherapy after surgery is as safe and effective for patients over 65 as for younger patients.”

Dr. Goldberg will present the 2008 Breaking Boundaries award to the exemplary
colorectal cancer survivors who have demonstrated an ongoing commitment to breaking down the myths associated with chemotherapy for the treatment of colorectal cancer in patients 65 years and older. They are:

• Carol Larson of Minneapolis, Minnesota – Recognized for her contributions in patient advocacy. Carol was diagnosed in 1999 with Stage III colorectal cancer, and has since undergone treatment with surgery and chemotherapy. Looking for information and support, Carol joined the Advocates for Colorectal Cancer (ACE), a patient-centered support group affiliated with the Minnesota Colon Cancer Coalition. Now she provides that support to others as a board member of ACE. In addition, Carol serves as the 2008-09 co- president of the Ostomy Association of Minneapolis.
• Kate Murphy of Skaneateles, New York – Recognized for her service to the online colorectal cancer community. Kate was diagnosed with Stage I colorectal cancer in 2007, her third bout of colon cancer. Since being diagnosed, she has been devoted to working with the Association of Cancer Online Resources to provide information and support through its integrated system of online discussion groups. Kate helps ACOR maintain its Internet mailing list focused on colorectal cancer. Recently, Kate received ACOR’s first Myth-Breaker Award in recognition of her dedication to the colorectal cancer community.
• June Melvin of Fair Oaks, California – Recognized for nearly 50 years of service to the Fair Oaks community and an ongoing commitment to improving the lives of its residents. First diagnosed with colorectal cancer in 2005, June underwent surgery and has been undergoing chemotherapy intermittently during the past year. Throughout treatment, June has continued her longstanding history of participation in local civic and political activities, such as her local historical society. In 2007, June was recognized for her exemplary service by The Woman’s Thursday Club of Fair Oaks and the Fair Oaks Historical Society.

Colorectal Cancer Most Prevalent Among 50+ Population
Colorectal cancer is the second leading cause of cancer-related deaths in the United States. The American Cancer Society estimates that more than 52,000 men and women died of colorectal cancer in 2007.

More than 90 percent of colorectal cancer cases are in people 50 and older. The elderly population has a significantly greater likelihood of developing CRC than do younger individuals. The American Cancer Society recommends that treatment not be withheld on the basis of age.

Learn about the honorees in the following videos:

Part One:

Part Two:

For more information on “Breaking Boundaries,” please visit: www.fightcolorectalcancer.org/events/breaking_boundaries. The program is co-
sponsored by sanofi-aventis.

About C3: Colorectal Cancer Coalition (C3)
C3 pushes for research to improve screening, diagnosis, and treatment of colorectal cancer; for policy decisions that make the most effective colorectal cancer prevention and treatment available to all; and for increased awareness that colorectal cancer is preventable, treatable, and beatable.

Posted by Judi Sohn on March 11th, 2008
Posted in: Policy & Advocacy News | 2 Comments »

Frankly Speaking About Colorectal Cancer — Free Workshop in Newark Delaware

The Wellness Community of Delaware will present a free workshop launching the newly revised, Frankly Speaking About Colorectal Cancer on March 15, 2008 in Newark, Delaware.

Frankly Speaking about Colorectal Cancer

• Saturday, March 15, 2008
• 9:15 AM – 2:00 PM, including lunch
• Helen F. Graham Cancer Center • Large Conference Room
• 4701 Ogletown-Stanton Road • Newark, DE 19713
• RSVP: The Wellness Community-Delaware, (302) 995-2850

Featured Speakers

• Opening Remarks
  Kim Thiboldeaux, President & CEO, The Wellness Community-National
  Carlea Bauman, President, Colorectal Cancer Coalition
• Bruce J. Giantonio, MD
  Abramson Cancer Center of the University of Pennsylvania
• Social and Emotional Issues for People Affected by Colorectal Cancer
  Jean Casper, LCSW
  Helen F. Graham Cancer Center
• Being Patient Active with Colorectal Cancer: A Survivor’s Panel
  Facilitated by TWC-Delaware Program Director Sean Hebbel, LCSW

The Wellness Community - Delaware is dedicated to helping people with cancer and their loved ones by providing professionally led programs of emotional support, education and hope as an integral part of conventional medical treatment.  All TWC programs are provided free of charge.

Frankly Speaking about Colorectal Cancer is a collaborative project of The Wellness Community nationally and C3:Colorectal Cancer Coalition.

March is National Colorectal Cancer Awareness Month

Colorectal Cancer is Preventable, Treatable, and Beatable

Posted by Kate Murphy on March 10th, 2008
Posted in: Research & Treatment News | No Comments »

C3’s 2008 Call-on Congress set to begin tomorrow

Forty advocates from across the US will come to Washington, DC, tomorrow to take the fight against colorectal cancer into the halls of Congress.

The C3 Call-on Congress will provide advocates with information about how the government weighs-in on colorectal cancer. They will hear from soldiers in the fight such as:

• Dr. Richard Goldberg, Chief of Hematology and Oncology at the Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, who will talk about how cuts to cancer funding are hurting colorectal cancer patients.
• Reverend Vaughn Profit-Breaux, a colorectal cancer patient who was diagnosed with colorectal cancer early thanks to a state program that is the model for HR 1738, which would guarantee access to colorectal cancer screening to the poor, uninsured and underinsured.

The advocates will then learn how THEY can make a difference for all colorectal cancer patients from leaders in the field such as:

• Jeff Martin, Director of Advocacy Training at the American Cancer Society, who will help the advocates learn how they can build an army of advocates back home.
• Ryan McKee, Legislative Director for Congressman Vito Fossella (R-NY-District 13), who will tell the advocates what to expect when they meet with their Members of Congress; and
• Christopher Kush, MPP, CEO of Soapbox Consulting, who has trained thousands of federal, state, and local advocates to effectively advocate for their issues.

On Tuesday, March 11th, the advocates will descend on Capitol Hill for face-to-face meetings with their Members of Congress and their staff. The advocates will be lobbying for the bills outlined in the Cover Your Butt Campaign and for an increase in cancer funding at the National Cancer Institute.

We’ll celebrate the advocates’ successful meetings at the C3 Advocates and Breaking Boundaries Awards Dinner on Tuesday evening, where we will undoubtedly hear about the many inspiring moments that took place on Capitol Hill that day.

The advocates attending the Call-on Congress come from all walks of life. There will be advocates in their 30s all the way up to their 80s. There will be patients, family members of patients, activists and widows. Many will be making their first trip to Washington, DC. Some of them are very sick.

As they make their way to Washington, DC, today, there is a good chance the advocates are terrified of what we have planned for them. But they come anyway because they are driven by the need to make the world better for themselves and for every other colorectal cancer patient out there. They are soldiers in the fight, and they are our heroes.

Posted by Carlea Bauman on March 8th, 2008
Posted in: Policy & Advocacy News | No Comments »