C3 President testifies at ODAC meeting on anemia drugs

image 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.

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