Fort Worth Star Telegram: Granger: FDA should continue patient access to "life extender" drug

Nov 10, 2010

BY KAY GRANGER

Special to the Star-Telegram

Recently, I spoke with a constituent who was diagnosed with metastatic breast cancer 17 years ago. She was 41 years old at the time.

After the diagnosis, her doctors told her she would have one year to live. Seven years later, she believed she had beaten the disease after going through traditional treatment options with no recurrence of the cancer.

The seven-year mark is an important milestone for breast cancer patients, who often believe that if they pass this point, there is a good probability that they have beaten the disease. Ten years after the original diagnosis, her cancer returned.

Doctors then prescribed a drug called Avastin. She experienced no side effects and could drive, work and live an active lifestyle. This has been a blessing for her.

Now, she is facing the prospect that Avastin will no longer be covered by her insurance, pending a decision by the Food and Drug Administration on Dec. 17. If the FDA does not approve the drug for breast cancer treatment, my constituent's insurance will no longer cover it and her access to the drug will be prohibited by cost. She considers an unfavorable decision a death sentence.

Extending the amount of time a patient has to live should be one of the primary objectives for a healthcare provider. For women suffering from breast cancer, it is impossible to quantify the value of any added time they can spend with their loved ones.

Avastin is expensive, but for a woman who has been diagnosed with metastatic breast cancer, any drug that can extend her life is priceless. The FDA's purpose is to make drugs available to the public that are life-saving or life-extending.

Patients have very limited options for approved medicines for metastatic breast cancer. Avastin is beneficial for at least 29,000 women diagnosed annually with HER2-negative metastatic breast cancer. If the FDA decides to revoke approval for Avastin, women like my constituent risk losing insurance coverage for this important drug.

After speaking with my constituent, I spoke with her doctor, Dr. Robyn Young of Fort Worth. Dr. Young said that in a study of continuous low-dose oral chemotherapy plus Avastin, 41 percent of patients had some shrinkage of the disease in response to the treatment, and another 41 percent had a stable disease.

This means that 82 percent of patients taking Avastin received some sort of benefit. Dr. Young emphasized that this was not a cure but rather a "life extender."

The FDA is continuing to review the information to determine whether Avastin can still be used to treat breast cancer. Regardless, we want to ensure that patients will continue to have access to this drug. The best people equipped to make healthcare decisions are the people closest to those decisions: doctors and patients.

It is my hope that the FDA will preserve patient/doctor choice based upon the evidence. I hope it will continue protecting the 29,000 women diagnosed annually with HER2-negative metastatic breast cancer. I hope it will allow patients and physicians the necessary options when it comes to coverage and therapeutic choices.

U.S. Rep. Kay Granger represents the 12th Congressional District, which includes the western half of Tarrant County and all of Parker and Wise counties.