Posted on 05/02/2012 9:39:52 PM PDT by T Minus Four
SALT LAKE CITY — A mom dying of cancer took to YouTube and inspired a pharmaceutical company to release to her a potentially life-saving drug before it was approved by the Food and Drug Administration.
A compassionate use clause allows for people with no other treatment options to receive experimental treatments prior to FDA approval, which is what Darlene Gant was hoping for on April 16 when she uploaded a 20-minute video to YouTube, pleading with the FDA approve her use of the drug Pertuzumab before its expected June approval date.
Gant, 46, had been told earlier in 2012 that her breast cancer had returned — stage four — and that she may not live to see the drug approved.
"I have a beautiful son, Cameron age 11 that is watching me die little by little each day, as well as my husband," she wrote on the video's homepage. "It is tearing us up and so many other families are going through this too … I am not expected to make it to June, my liver is engulfed with tumors and I am wasting away."
The video, unplanned according to Gant, shows the mom reading cards she had written for her son to read between the ages of 12 and 25 at birthdays, graduation and at his wedding.
"Did you always know I loved you?" she wrote in a card for his 12th birthday. "Of all the things in my life I could have or should have done differently, there's one thing I'd never change, having you as my son."
She said she just wants him to know she cared.
"I am trying to leave him pieces of me to comfort him and let him know how much I love him - he is my world," she wrote. "I can handle dying but not leaving my son. You see I want to finish my mission here and raise my baby to manhood."
The Tampa Bay, Fla., woman was first diagnosed with breast cancer when her son was 5 years old. She said her son will never remember what it is like to have a mom without cancer.
It is tearing us up and so many other families are going through this too … I am not expected to make it to June, my liver is engulfed with tumors and I am wasting away. –Darlene Gant"It's pretty sad that cancer has taken my life to this point, and I have to plan what I'm going to do so he remembers me," she wept.
Gant's video garnered tens of thousands of page views within its first two weeks online and inspired many people to call the drug's maker — Genentech — to plead for the release of the drug.
Gant originally thought the FDA had been prohibiting the drug's release, but according to FDA officials they had approved the compassionate use — it was up to Genentech to decide what to do with it.
Gant's unorthodox method worked: The company eventually decided to release the drug to her, and she received her first treatment on April 27.
The FDA has given Pertuzumab priority review status due to the drug's success at treating HER2-positive breast cancer, which contains a protein that promotes the growth of cancer cells. The mutation happens in about one in five breast cancers.
HER2-positive breast cancers tend to be more aggressive and less responsive to hormone treatment than other breast cancers.
The confirmed date for the FDA-review of Pertuzumab is June 8.
Why shouldn’t patients have the general right to buy ANY pre-approval drug on signing a release confirming that they are knowingly taking an experimental medication that has not yet completed the approval process?
Because one, that’s too easy, and two, government must have absolutely control over all our lives and everything contained in those lives, including potentially life saving treatments and medications.
I couldn’t hate cancer more if I tried. It’s such a bizarre, horrible disease. I’m glad this woman was given another shot at treatment. I hope she wins. As far as access to experimental treatments, I say go for as long as you sign a waiver. The problem is that people will sign, and then family will Sue when it turns you green or your feet fall off.
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