Founded in 1970 by concerned parents of children with cancer, the group also engages in legislative dialogue on issues relating to cancer and cancer treatments.

       Children with cancer continue to be treated primarily with drugs that were developed 20-30 years ago. Scientifically, researchers have reached an era where new types of 'smart drugs' can be developed to treat cancer at a genetic level. These new types of cancer treatments have started to be developed for adult cancers and have showed great promise for cure. Children with cancer need these types of new drugs to give them Hope for a complete cure.

      Current debates in both the House and Senate could eliminate such future development of targeted drugs for children with cancer and other rare diseases. To protect biotech development of such essential biologic products, Ruth and the Foundation have begun a petition to support the “Patient Protection and Innovation Biologic Medicines Act of 2007.”

·           Because treatment for children with cancer has not changed significantly in recent years and we are eagerly awaiting a major breakthrough.
 

Q&A with Ruth Hoffman, Candlelighters Childhood Cancer Foundation Executive Director

Q: What is the Candlelighters Childhood Cancer Foundation?

A: Candlelighters Childhood Cancer Foundation was founded in 1970 by concerned parents of children with cancer. Its mission is to provide information and awareness for children and adolescents with cancer and their families, to advocate for their needs, and to support research so every child has the opportunity to survive and lead a long and healthy life.

Today, we have a membership of over 50,000 through our national office and more than 100,000 members across the country linked to our 37 affiliate offices in 28 states.

We also participate in legislative dialogue on issues pertaining to cancer and cancer treatments.

Q: What is your organization’s main legislative issue?

A: Candlelighters Childhood Cancer Foundation strongly supports research into breakthrough medicines and fully supports increasing access to affordable drugs. The current treatment options for children are scarce. Children with cancer continue to be treated solely with highly toxic cancer drugs that were developed 20 to 30 years ago.

Only one new drug has received marketing approval by the FDA for childhood cancer in the last decade.

These traditional chemotherapy drugs have not provided a cure for many childhood cancer tumors, and they leave those children who do survive to face lifelong late-effects, including severe drops in IQ, heart damage, sterility, deafness and – most shockingly – secondary cancers. As a result, cancer remains the number one disease killer of America’s children – more children still die from cancer than Cystic Fibrosis, Muscular Dystrophy, Asthma, and AIDS combined.

The dangers of these conventional and outdated drugs mean we have to work hard to find new treatments.  However, biologics, which are complex therapies developed from human and animal proteins, have shown significant promise in successfully treating cancer in children. So much in fact, that Congress is now considering several versions of legislation to develop standardized methods for FDA approval of “follow-on” – or generic – versions of biologic drugs, as original patents for these drugs will soon expire and at this time U.S. law does not have an approval process in place.

Q:  Why are these standardized methods of FDA approval important for cancer patients?

A: We have reached a breaking point for childhood cancer. Treatment for children has not changed significantly. In addition, mortality rates for children with cancer have not changed in the last decade.  Two-thirds of those who do survive are faced with life-long late effects, one-third classified as moderate to life-threatening.  We are losing the battle against childhood cancer.

The hope to reverse this downward trend is through innovation. Biologic drugs have proven to be effective weapon in treating adult cancer and are one of most promising treatments for the future. Because conventional treatments are so dangerous to children, as they are given during a time in their lives when they have growing bodies and developing brains, young cancer patients are depending on innovative biotech companies to continue to develop more effective and targeted treatments in the future.

While the Candlelighters Childhood Cancer Foundation fully supports increasing access to affordable drugs, we are opposed to any legislation that would decrease the incentives for companies to invest and discover breakthrough therapies. It is estimated that a biotech company will spend 15 years and $1.2 billion to develop one new biologic alone.

To help maintain incentives for innovation, we support legislation introduced by Representative Jay Inslee (D-WA). His bill, the "Patient Protection and Innovative Biologic Medicines Act of 2007" (H.R. 1956) establishes an appropriate balance between reducing cost, ensuring safety and providing incentives for innovation. Most importantly, the bill will help to increase incentives for biotech companies to develop targeted therapies for children with cancer.

Q:  What other versions of this bill are being considered by Congress? Are they all the same?

A: No. While we support the bill proposed by Representative Inslee, the Candlelighters Childhood Cancer Foundation is opposed to Representative Henry Waxman’s bill, H.R. 1038, the "Access to Life-Saving Medicine Act."

At this time, current scientific techniques can not verify that generic copies of biologic medicines are identical. This raises serious concerns regarding the safety of any follow-on biologic. Mr. Waxman’s bill does not require the FDA to demand additional clinical trials by the generic companies for marketing approval. As a mother, I would not allow my child to be administered a drug that can not scientifically be proven to be safe.

Second, Mr. Waxman’s bill would allow the generic copy to be given the same name as the original biologic. In post-marketing monitoring for safety, it would be impossible to differentiate between the two products if there were issues of safety with the follow-on biologic.

Finally, Mr. Waxman’s bill creates an abbreviated marketing exclusivity clause for follow on biologics. This provision would reduce incentives for biotech companies to invest in the research and development of innovative biologics. 

A policy that produces more copies and less innovation will not help the children and their families living with cancer. During My testimony (PDF) before the House Energy and Commerce Committee, I urged members not to pass legislation that cuts costs by reducing incentives for biotech companies to develop targeted therapies for cancer. For me, and for the parents I represent, life-saving therapies trumps cost-saving any day.

Q. What can the public do to help?

A: I urge people who are concerned and want to maintain the pipeline of breakthrough medicines for cancer patients and other diseases to sign the petition on the Candlelighters Childhood Cancer Foundation Web site, which urges Members of Congress to preserve innovation and support Congressman Inslee’s legislation.

About Ruth:

Ruth Hoffman is the mother of eight children, including a 23 year old daughter Naomi, who is a 16 year survivor of Acute Myeloid Leukemia (M5). Since 1999, Ruth has been the Executive Director of the national office of Candlelighters Childhood Cancer Foundation. In addition to membership on C-Change (formerly the National Dialogue on Cancer co-chaired by former President George & Barbara Bush and Senator Dianne Feinstein), Ruth is a patient consultant for the FDA, serves on the Alliance for Childhood Cancer, the National Coalition for Cancer Research, the American Cancer Society's Children and Cancer Advisory Group, the IRB of Children's National Medical Center, Washington D.C. and is a rotating member of the FDA's Pediatric Subcommittee of the Oncology Drug Advisory Committee.

Ruth's leadership has resulted in the recent publication of Chemo, Craziness & Comfort, a 200 page educational text written for the elementary aged child who has been diagnosed with cancer, a 28 page picture book entitled The Amazing Hannah, published in both English and Spanish for preschool cancer children, and a comprehensive 335 page book Educating the Child with Cancer, A Guide for Parents and Teachers. Ms. Hoffman provides a patient navigation program and personally responds to thousands of requests for childhood cancer treatment information annually. She is co-founder and organizer of Candlelighters National Childhood Cancer Awareness Tree.

Candlelighters Childhood Cancer Foundation
P.O. Box 498
Kensington,  MD  20895-0498
Phone:  800-366-2223
Fax:  301-962-3521
Email:  staff@candlelighters.org
Web Site: http://www.candlelighters.org