When Cancer Gets Political

Started by anonymous, February 02, 2015
5 replies for this topic
anonymous

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Posted on
February 02, 2015
When you get a cancer diagnosis, your whole world flips upside down. Your focus shifts to treatments, side effects, scans and statistics. Sometimes, however, politics creep in.

The Food and Drug Administration has just announced that it plans to begin a new level of oversight for laboratory developed tests (LDTs). I, and many others with cancer, think this is a terrible idea.

But wait, you say, isn't FDA oversight a good thing? We all want to stay safe!

Absolutely! I want to know that I am safe, and oversight is necessary and beneficial!
 
However, there already is oversight. These laboratories currently undergo a certification process by the Centers for Medicare and Medicaid services, as well as other accreditation agencies. This new FDA regulation adds an additional, time-consuming hoop that will slow down testing of things like cancer mutations.

Those of us with metastatic cancer don't have years to wait for FDA approval of these genetic tests.

I have a rare mutation that drives my cancer's growth, and I am currently living well on a daily pill developed to target that mutation. When my lung cancer finds a way around this pill - which it inevitably will - I will be counting on these laboratories to test that cancer growth and find a new treatment for me. Cancer moves fast; we need to move faster.

Our understanding of cancer is developing at an incredible rate, and laboratories need the freedom to react quickly, developing and tweaking these tests without having their hands tied by slow, unnecessary extra oversights.

Fellow stage 4 lung cancer patient Janet Freeman-Daily wrote eloquently about this proposed legislation: "Of course, we all want LDTs to be as validated, accurate and clinically relevant as possible. However, we also want the laboratories where these clinical testing services are performed to be able to exercise the flexibility, innovation and medical judgment necessary for good outcomes in thousands of cancer patients.  This isn’t possible with the proposed FDA regulations."

Have you had genetic testing? Has you tumor been tested for mutations? This new legislation could stand in the way of that happening for you or others in the future.
 
If you have cancer, this impacts you.
If a family member has cancer, this is important.
Please take a moment to sign the petition, and encourage those who care about you to do the same.

(Still not sure? At least click the link below and read more about the reasoning behind this petition. It could change the course of your life.)

Tell the FDA to withdraw its proposed regulations for laboratory developed tests (LDTs). These regulations could limit patient access to life-saving tests and therapies.
The link: http://chn.ge/1uN2e2Z


Tori Tomalia is many things: a mom, a wife, a theatre artist, a mediocre cook, a Buffy fan, a stinky cheese aficionado. She is also, unfortunately, a repeat visitor to Cancerland. Stay tuned for her continued adventures (http://www.curetoday.com/community/tori-tomalia).You can follow her blog at "A Lil Lytnin' Strikes Lung Cancer" http://lil-lytnin.blogspot.com/



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Anonymous

Member
0 Replies
Posted on
February 02, 2015
When you get a cancer diagnosis, your whole world flips upside down. Your focus shifts to treatments, side effects, scans and statistics. Sometimes, however, politics creep in.

The Food and Drug Administration has just announced that it plans to begin a new level of oversight for laboratory developed tests (LDTs). I, and many others with cancer, think this is a terrible idea.

But wait, you say, isn't FDA oversight a good thing? We all want to stay safe!

Absolutely! I want to know that I am safe, and oversight is necessary and beneficial!
 
However, there already is oversight. These laboratories currently undergo a certification process by the Centers for Medicare and Medicaid services, as well as other accreditation agencies. This new FDA regulation adds an additional, time-consuming hoop that will slow down testing of things like cancer mutations.

Those of us with metastatic cancer don't have years to wait for FDA approval of these genetic tests.

I have a rare mutation that drives my cancer's growth, and I am currently living well on a daily pill developed to target that mutation. When my lung cancer finds a way around this pill - which it inevitably will - I will be counting on these laboratories to test that cancer growth and find a new treatment for me. Cancer moves fast; we need to move faster.

Our understanding of cancer is developing at an incredible rate, and laboratories need the freedom to react quickly, developing and tweaking these tests without having their hands tied by slow, unnecessary extra oversights.

Fellow stage 4 lung cancer patient Janet Freeman-Daily wrote eloquently about this proposed legislation: "Of course, we all want LDTs to be as validated, accurate and clinically relevant as possible. However, we also want the laboratories where these clinical testing services are performed to be able to exercise the flexibility, innovation and medical judgment necessary for good outcomes in thousands of cancer patients.  This isn’t possible with the proposed FDA regulations."

Have you had genetic testing? Has you tumor been tested for mutations? This new legislation could stand in the way of that happening for you or others in the future.
 
If you have cancer, this impacts you.
If a family member has cancer, this is important.
Please take a moment to sign the petition, and encourage those who care about you to do the same.

(Still not sure? At least click the link below and read more about the reasoning behind this petition. It could change the course of your life.)

Tell the FDA to withdraw its proposed regulations for laboratory developed tests (LDTs). These regulations could limit patient access to life-saving tests and therapies.
The link: http://chn.ge/1uN2e2Z


Tori Tomalia is many things: a mom, a wife, a theatre artist, a mediocre cook, a Buffy fan, a stinky cheese aficionado. She is also, unfortunately, a repeat visitor to Cancerland. Stay tuned for her continued adventures (http://www.curetoday.com/community/tori-tomalia).You can follow her blog at "A Lil Lytnin' Strikes Lung Cancer" http://lil-lytnin.blogspot.com/



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Anonymous

Member
0 Replies
Posted on
February 02, 2015
Just signed. Thank you for this post, Tori!
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Anonymous

Member
0 Replies
Posted on
February 02, 2015
Thank YOU, Kristin!
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Anonymous

Member
0 Replies
Posted on
February 03, 2015
Tori, very well written. I can see why CURE asked you to write this regular column. If it wasn't for Tarceva and AZD9291, I might not be around. Already signed the petition and shared it to my Facebook buds. Take care.
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Anonymous

Member
0 Replies
Posted on
February 03, 2015
Thanks, Craig. I am so glad the trial is working for you. Yeah, us mutants are counting on this stuff! Thanks for sharing the petition.
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Anonymous

Member
0 Replies
Posted on
February 05, 2015
I'm trying to figure out the best way to get involved to speed up FDA approval of PRRT, (Peptide Receptor Radionuclide Therapy,) for metastatic Neuroendocrine Cancer/Carcinoid Syndrome. Available inexpensively for almost twenty years in Europe, this promising treatment is just recently being given in randomized clinical trials here in the US. It is very costly to get this targeted radiation IV medication in Europe, and patients are forced to choose other treatments that are potentially more harmful, but covered by insurance here, or to go to Europe at a cost of about $15,000.00 per treatment, (usually about four treatments are involved.) So frustrating!!! Some patients most definitely don't have the time to wait while the FDA makes the scientists, docs, drug companies and patients jump through eccessive hoops!
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