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Old 05-28-2011, 06:33 PM   #1
Soccermom
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Exclamation FDA hearing June 28 re: AVASTIN

At the FDA hearing on Avastin on June 28, up to 2 hours have been reserved for public presentations. If you wish to make an oral presentation during this hearing, you must register by submitting an electronic or written request by May 27, to:

Talisha Williams
Office of the Ombudsman, Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
301-796-8530
email: Talisha.Williams@fda.hhs.gov

Depending on the number of requests, FDA may not be able to honor all such requests. You must provide your name, title, business affiliation (if applicable), address, telephone and FAX numbers, email address, and (if applicable) type of organization you represent (e.g., industry, consumer organization). You also should submit a brief summary of the presentation, including the discussion topic(s) that will be addressed and the approximate time requested for your presentation.

FDA Hearing Info
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Old 05-30-2011, 04:54 AM   #2
Jackie07
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Re: FDA hearing June 28 re: AVASTIN

Thanks, Marcia.

Incidentally, I saw this article discussing the 'cost' issue of chemotherapy from the oncologists' point of view (scary) printed in the New England Journal of Medicine:

http://www.nejm.org/doi/full/10.1056/NEJMsb1013826
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Last edited by Jackie07; 05-30-2011 at 05:06 AM..
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Old 05-30-2011, 05:01 AM   #3
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Re: FDA hearing June 28 re: AVASTIN

Oncologists React to Cost-Cutting Editorial

By Kristina Fiore, Staff Writer, MedPage Today
Published: May 28, 2011

One way to curb rising cancer costs may be to cut back on chemotherapy regimens -- specifically if they're producing no effects after three consecutive rounds.

That's one of 10 recommendations put forth in a New England Journal of Medicine commentary by Thomas Smith, MD, and Bruce Hillner, MD, of Virginia Commonwealth University -- who may be trying to spark debate just ahead of this year's annual meeting of the American Society of Clinical Oncology.

Smith and Hillner argue that spending on cancer treatment must be curbed because it is spiraling out of control, predicted to rise from $104 billion in 2006 to $173 billion in 2020 -- largely driven by rises in the cost of therapy and the extent of care.

"We must find ways to reduce the costs of everyday care to allow more people and advances to be covered without bankrupting the healthcare system," they wrote.

To achieve that, the researchers outlined 10 recommendations for oncologists: five regarding behavior and five focusing on attitudes and practice.

Perhaps their most contentious point was limiting chemotherapy regimens to only three if the patient does not respond well -- restricted, of course, to those with incurable solid tumors.
The idea evoked a strong response from several clinicians contacted by MedPage Today and ABC News.

While some said this recommendation largely reflects the way they've already been practicing, others argued that cancer treatment cannot be so generalized, since there are multiple variables including the type of disease, the available treatments, and the patient's response.

"Reasonable people could accept an approach that allocated resources where they were likely to be effective and withheld resources when they were not likely to be effective," Rosamond Rhodes, PhD, of Mount Sinai School of Medicine in New York City, said in an email.

"In the circumstance in which a person has shown no benefit from three consecutive regimens of chemotherapy, and offering another regimen is not likely to be effective, withholding further ineffective interventions could be acceptable," she added. "A rationing scheme based on a low efficacy standard and applied to all patients with all diseases, could be just, fair, and reasonable."

On the other hand, Bayard L. Powell, MD, of Wake Forest University in Winston-Salem, N.C., warned that treatment decisions are complex, and physicians should make decisions on an individual basis.

"Chemotherapy can be expensive and can be toxic, but it can improve both the quality and duration of life for many patients," Powell said in an email. "It would be very difficult, and inappropriate, to make broad generalizations about how to best use these therapies in a diverse group of patients with cancer."

And being denied treatment -- even if it may not be effective -- is not something patients want to hear, experts said. Herbert Kressel, MD, of Beth Israel Deaconess Medical Center in Boston, relayed the experience of his mother-in-law, who had failed three regimens.

"Her oncologist recommended no further treatments," Kressel said in an email. "Her son, a physician, argued vehemently against this and persuaded the oncologist to go one more round. Needless to say, she was totally cured and lived over 10 additional disease-free years."
Among the other recommendations regarding oncologists' behaviors were getting with the guidelines to cut out surveillance testing with serum tumor markers, and using sequential monotherapy instead of combination regimens for recurrent disease.

They also called for limiting chemotherapies on the basis of patient performance (they should be able to walk themselves into the clinic, Smith and Hillner wrote) and for reducing chemotherapeutic dose as an alternative to giving expensive hematopoietic colony-stimulating factors afterwards, which have shown little benefit.

In terms of physician attitudes and practice, the editorialists called for more talks with patients about end-of-life care, offering better informed consent regarding their expectations, and improved integration of palliative care.

As well, governments and payers should have more discussions about cost-effectiveness and comparative effectiveness, and there should be a change reimbursement so that payments aren't so tied to chemotherapy, they said.
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http://www.kevinmd.com/blog/2011/06/doctors-letter-patient-newly-diagnosed-cancer.html
http://www.asco.org/ASCOv2/MultiMedi...=114&trackID=2

NICU 4.4 LB
Erythema Nodosum 85
Life-long Central Neurocytoma 4x5x6.5 cm 23 hrs 62090 semi-coma 10 d PT OT ST 30 d
3 Infertility tmts 99 > 3 u. fibroids > Pills
CN 3 GKRS 52301
IDC 1.2 cm Her2 +++ ER 5% R. Lmptmy SLNB+1 71703 6 FEC 33 R Tamoxifen
Recc IIB 2.5 cm Bi-L Mast 61407 2/9 nds PET
6 TCH Cellulitis - Lymphedema - compression sleeve & glove
H w x 4 MUGA 51 D, J 49 M
Diastasis recti
Tamoxifen B. scan
Irrtbl bowel 1'09
Colonoscopy 313
BRCA1 V1247I
hptc hemangioma
Vertigo
GI - > yogurt
hysterectomy/oophorectomy 011410
Exemestane 25 mg tab 102912 ~ 101016 stopped due to r. hip/l.thigh pain after long walk
DEXA 1/13
1-2016 lesions in liver largest 9mm & 1.3 cm onco. says not cancer.
3-11 Appendectomy - visually O.K., a lot of puss. Final path result - not cancer.
Start Vitamin D3 and Calcium supplement (600mg x2)
10-10 Stopped Exemestane due to r. hip/l.thigh pain OKed by Onco 11-08-2016
7-23-2018 9 mm groundglass nodule within the right lower lobe with indolent behavior. Due to possible adenocarcinoma, Recommend annual surveilence.
7-10-2019 CT to check lung nodule.
1-10-2020 8mm stable nodule on R Lung, two 6mm new ones on L Lung, a possible lymph node involvement in inter fissule.
"I WANT TO BE AN OUTRAGEOUS OLD WOMAN WHO NEVER GETS CALLED AN OLD LADY. I WANT TO GET SHARP EDGED & EARTH COLORED, TILL I FADE AWAY FROM PURE JOY." Irene from Tampa

Advocacy is a passion .. not a pastime - Joe

Last edited by Jackie07; 05-30-2011 at 05:04 AM..
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Old 06-29-2011, 03:46 PM   #4
Soccermom
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Re: FDA hearing June 28 re: AVASTIN

Todays update from Genentech in the hearing that was held...
http://www.gene.com/gene/products/information.html
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