Monday, August 22, 2011

Strong-arming the FDA

I lost 3 lb. this weekend. It wasn't a special kind of diet (I don't need to lose weight). It was a special kind of exercise that's rarely done these days: writing. You know, by hand. 

A cyber-friend and sister cancer survivor, Jeanne Sather, is trying to get expanded access to the experimental drug T-DM1, which has put her metastatic breast cancer into remission. Expanded access would mean she could receive the drug in Seattle, her hometown, instead of spending $1,400 every three weeks to fly 900 miles to the study site in Southern California. She has run out of money and endurance for the three-day trip. 

So I hand-wrote five letters to FDA officials involved in the decision to grant or withhold expanded access. It has been a long time since I hand-wrote anything longer than my signature on a credit-card receipt, and it was surprisingly strenuous—and time-consuming—to eke out these letters. My right arm was throbbing by the end! But it was a soreness to be savored. It isn't every weekend that I spend doing something righteous.

Here's the link to Jeanne's YouTube video about her predicament:

Here's the link to her blog: assertive

Here's my letter:

"If you could extend a person’s life without imperiling anyone else’s, you would do it, right? You can—by granting expanded access to Jeanne Sather for the experimental breast-cancer drug T-DM1.

"Jeanne was diagnosed with breast cancer 13 years ago, when she was 43. In the past 10 years, it has metastasized to her brain, bones and lungs. Through her own ingenuity and that of her doctors, she has repeatedly managed to block her cancer’s progression. About a year ago, she ran out of treatment options. Then she began a trial with the experimental drug T-DM1, which put her cancer into remission. Despite the drug’s miraculous effect, Jeanne may be forced to give up treatment. She has no more money to pay for the trips to and from Seattle, where she lives, and Southern California, where she has been receiving the drug. T-DM1 is available only at study sites, and there are no study sites in Washington State.

"Jeanne, who once earned her living as a journalist, now lives on Social Security Disability and is on the verge of losing her home and declaring bankruptcy. Despite her difficulties, she remains a towering figure in the cancer community. Her blog, The Assertive Cancer Patient, is an important emotional and informational resource for women enduring this deadly and terrifying disease. In the pink-ribbon fanfare that surrounds breast cancer, women with metastatic disease are often ignored. But Jeanne has insisted on being visible and documenting in unvarnished detail the reality of living with metastatic cancer. She has become a human switchboard in the cancer community. As a sister breast-cancer patient and a faithful reader of her blog, I take a selfish interest in the longevity of this most generous of women.

"Please help keep Jeanne alive by granting her expanded access to T-DM1 so that she can receive it in Seattle."

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