Principles of Medical Ethics 

Before You Donate

Think very seriously before donating to any breastcancer organization, or fundraising program until you read their Annual Report to see who their top contributors are, and if they have a product that appears frequently in the message the organization sends to the public. That would be unethical and its illegal. The same applies to a request that the public buys products, but does not receive a "donor receipt" for tax-deductible purpose. Read any and all food labels that breastcancer "non-profits" are promoting to raise money. Some organizations tell the public to help them raise money by asking you to visit their websites, but that only gives them "hits" to increase their sponsors.

Another tip, "signing" an online Petition is not acceptable, so don't fall for such antics. An ethical non-profit, or professional will not request your visit to their website, nor use "cookies" placed on your computer when you visit their site.

Purchase the Breastcancer Postage Stamp, the Post Office will always give you your charitable deduction receipt. Its a valid form of fund raising.

 

"Can you help me?  My oncologist wants me to take Taxol, as well as the other, (red stuff) Adriamycin, and Cytoxin?  Is this possible?  Is it right?"

Oh dear, I cannot give you a medical opinion, my site is to help you become an informed, active healthcare consumer, and the steps you need to take. However, here are articles which I'd suggest you take to your oncologist, and if you are in question still, I'm sure your Oncodoc will get you to a 2nd and/or 3rd opinion.  AND, most importantly, s/he must give you time. This was early studies, and there are new ones now, that have suggested other drugs for antiangiogenesis (2005) that appear more effective but the Paclitaxel (Taxol) are still being used in combination with Adriamycin, Cytoxin, radiotherapy, and monoclonal antibodies. I have to question, how do we know which, or what, is working over the course of treatment?

I will add links at the bottom for new data in 2005 from the ASCO Meeting this year (American Society of Clinical Oncologists).

When someone has been as fortunate as I have with a very caring, thorough, well-educated oncodoc, it is hard for me to imagine some of the reports I'm getting from users of my site.  But, you have a right to every bit of information you can get, and you also have a right to be taught about cancer, cell types, what is expected from your cell type, it's phase/grade, etc.

Personally, I favored total mastectomy each time (granted, that was my surgeon's mandate, or find another surgeon) and  chemotherapy because I personally do not trust that radiation will not affect my spinal column/cord, lungs, etc. But, that is my opinion, based on my own research and countless hours talking to physicians I greatly respect.

Would I take it if my Oncodoc advised it? Probably not because I know that he, and the rest of my team would concur, and would have given it serious consideration and they are there for me. As of right now, I'm an equal member of that team, and also responsible.

In a nutshell, that is what this web site is for! If you need an advocate, send me an E-Mail, and I will help you find one...there are thousands of us in our web rings ready to help you out, as well as R.N.s, mammography technologists, and of course the caring physicians (and there are caring physicians!!).

FDA Advisers Back Taxol to Boost Chemo Performance in Early Breast Cancer
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SILVER SPRING, MD, Sept 20 (Reuters Health) - Food and Drug Administration (FDA) advisers on Friday unanimously recommended approval of Bristol-Myers Squibb's Taxol (paclitaxel) as a sequential therapy after doxorubicin-based chemotherapy to boost cure rates and survival.

The drug would be for women getting chemotherapy to prevent recurrence after surgical removal of tumors. In the pivotal study, the largest ever conducted in the adjuvant setting for node-positive breast cancer, adding Taxol cut the risk of recurrence by 20% and reduced mortality by 26%.

These figures were reported at the American Society of Clinical Oncology (ASCO) in May 1998, but have been updated to include more patients and a longer median follow-up30 months, compared to the 20 months reported at ASCO.

The study, encompassing 3,121 patients, was conducted by four National Institutes of Health-funded trial groups: the Cancer and Leukemia Group B, the Eastern Cooperative Oncology Group, the Southwestern Oncology Group, and the North Central Cooperative Treatment Group. After consulting with these groups, Bristol-Myers asked FDA in April 1999 to approve Taxol as sequential therapy.

Despite compelling efficacy results, the drug did not seem to work as well in patients with estrogen receptor positive tumors. Bristol-Myers happened upon the data -- it was not a planned subset analysis.

All 3,000 women received one of three doxorubicin (Adriamycin) doses plus cyclophosphamide, for four cycles every three weeks, and then either intravenous Taxol (175mg/m2 for three hours) for four cycles or no Taxol. Women with receptor positive tumors also began taking tamoxifen at week 24, and were to continue taking it for five years.

The FDA recommended against approval for this group of women, based on the subset analysis. Reviewer James O'Leary said there was a 34% decrease in risk of relapse and a 10.5% difference in three-year disease-free survival in negative receptor women, while there was no difference in three-year rates in receptor positive patients who took tamoxifen. There were 325 recurrences in 1,033 receptor negative patients, compared to 258 recurrences in 1,913 receptor positive patients who took tamoxifen.

"There seems to be no evidence of benefit after four cycles," in the tamoxifen patients, Dr. O'Leary said, adding that for this group, taking Taxol would not be worth the risk. He said that overall, 82 patients discontinued Taxol therapy because of neurosensory and hypersensitivity problems. Two patients died during Taxol therapy. The deaths seemed drug-related, said Dr. O'Leary.

Panelists were wary of basing a recommendation on a subset analysis.

"The damage we would do by withholding the drug with the knowledge base we have is more than the damage we would do by letting the drug through," said panelist Derek Raghavan of the University of Southern California.

But committee members admitted it caused them to hesitate. Panelist David Johnson of Vanderbilt University said when he first saw the data, he planned on using sequential Taxol in his receptor-positive patients, but was not as sure now. But, he added, "It seems we ought to accept the data from this large, powerful trial," and add subset data to labeling"

Note: Bold font above is this web site owner's insertion. We had a patient at Vanderbilt who suffered considerable side effects from Taxol. Her condition worsened, generally. She gave PROJECT! OUTREACH a legal release and all of her medical files so her story would be told. Seeing Vanderbilt mentioned herein, it reminded me of her. And...as I said earlier on this web site, in 1999 in fact, Tamoxafin would "not be utilized for long, and definitely not in hormone receptor positive patients" it isn't in 2005 and wasn't by the end of 1999 by intelligent oncologists.

Taxol Receives Approval For Early-Stage Breast Cancer Indication


WESTPORT, OCT 28 (Reuters Health) - Bristol-Myers Squibb's paclitaxel (Taxol) has received Food and Drug Administration approval for adjuvant treatment of early-stage, node-positive breast cancer after doxorubicin-based chemotherapy.

The FDA approval follows a unanimous September recommendation for approval of this indication by an advisory panel to the agency. As reported by Reuters Health on September 20, studies on more than 3,000 patients demonstrated that Taxol cut the risk of recurrence of node-positive breast cancer by 20% and reduced mortality by 26%.

Taxol was previously approved for marketing in the US for some advanced cancers and lung and ovarian cancers. The drug generated revenues of around $1.2 billion in 1998.

Although approval for this indication is not expected to have a major sales impact, Gruntal & Company drug analyst David Saks said that the approval would add "...to the depth and breadth of Taxol." He added, "The drug has become ubiquitous in chemotherapy."

In Wednesday afternoon trade, shares in New York-based Bristol-Myers Squibb climbed 1-7/8 to 73-15/16.


The inclusion of the Wall Street aspects of this drug should bring all of us to question the research, approval, and appropriateness of use in addition to Adriamycin and Cytoxin.

One must think what a 20% cut in recurrence and 26% reduced mortality really means and how many months was that data covering? I think it was only 30 months...not enough for me to take it.

Update: http://www.peerviewpress.com/dedicated.do;jsessionid=56411654EC59591ECD21507C2E442DD8?page=onmay05t&inReel=2&dist=t&num=2&cme=1&id=5E5D6B56-CBD0-4682-84F5-B25E8BFF2626&value=192

 

 

Reviewed: Thursday, September 01, 2005