FDA says no to Avastin for breast cancer

tousled1 · 12-05-2007, 09:34 PM

I know this should be posted under news but wanted to make sure everyone saw it.

http://news.yahoo.com/s/hsn/20071206...buc1U5vXfVJRIF

Sheila · 12-06-2007, 09:17 AM

Thanks Kate for posting this...I wonder if the insurance companies will quit paying for it now as it is about 20,000 per treatment...guess I better check before I get my next one...I put a call in to my oncologist!

Mary Jo · 12-06-2007, 09:25 AM

I didn't read the link that Kate posted so not sure what the reasoning was. I can say though, that I was disappointed it seeing that the FDA didn't approve something that seems to benefit many. Dang!

Mary Jo

Jean · 12-06-2007, 10:25 AM

this news article is interesting...I find it strange that the panel has advised FDA not to pass the drug, since it is currently being used for other cancers (colon and lung) and has shown to be benifical to bc patients with advanced stage disease. Let's hope the FDA will pass the drug in Feb. My onc. who is very cauious is excited about passage of this drug and felt it would be approved by the FDA....I hope he is correct.

We all know that these drugs can create negative or fatal results in any given population of drugs. Those percentages are small - and unfortunately it can happen.

I do not understand why a drug would be denied to bc patients when it is being given to others who are fighting cancer? Let's hope Avastan will be approved in Feb. by the FDA...This somehow reminds me of the early horror stories I was told about Herceptin and heart failure. Everytime I discussed Herceptin...the dr. would shout out the fatal side effects of herceptin...and this was just back in 2005....

In the earlier days the dr. did not know to halt the A/C and then administer herceptin...what if they shelved herceptin becasue of the
percentage of fatal results ? The percentages are small with negative results with Avastan and prolonged survival percentages are better.
I thought the panel was wrong when they said the time was not acceptable (5months for survival) just think - who knows what could be developed in 5 months ....

Jean

Kim in CA · 12-06-2007, 12:08 PM

On a somewhat related note....

Don't know if this is old news to some of you, but found this article in our local paper to be very troubling. Was thinking this could possibly impact our ability to see these drugs get approval.

<TABLE class=lead><TBODY><TR><TD class=lead>Report says FDA troubles leave food supply at risk

Federal agency suffers from lack of funds, tech problems, advisers say

By GARDINER HARRIS
NEW YORK TIMES

WASHINGTON -- The nation's food supply is at risk, its drugs potentially dangerous, and its citizens' lives at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to a report by agency advisers.

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The report, made public Friday, is the latest and perhaps most far reaching in a string of outside assessments that have concluded that the FDA is poorly equipped to protect the public health.

It was written by three members of the FDA Science Board, an advisory board that reports directly to the agency's commissioner, Andrew von Eschenbach. The three authors in turn had 30 scientific advisers.

The report concludes that over the last two decades the agency's public health responsibilities have soared while its appropriations have barely budged. The result is that the FDA is falling further and further behind in carrying out its responsibilities and understanding the science it needs to do its many jobs.

"FDA's inability to keep up with scientific advances means that American lives are at risk," the report stated.

Sandy Walsh, a spokeswoman for the FDA, said the agency "values the evaluation done by the subcommittee members and the scientific experts that were consulted" but would not comment further.

Barbara McNeil, a professor of health care policy at Harvard Medical School and one of the report's authors, said she was stunned at the agency's sorry state.

"This was the first time that a group of people got together and really looked at all the areas that the FDA has to cover," McNeil said. "We were shocked at the scope of its responsibilities, we were shocked at how little its resources have increased, and we were surprised at the conditions those in the FDA had to work under."

The report notes that the agency's computer systems are aging and prone to breakdowns, "most recently during an E. coli food contamination investigation."

The report stated that "Reports of product dangers are not rapidly compared and analyzed; inspectors' reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with customs and other government systems."

The agency often misses significant product arrivals because its computers are so poor that they cannot distinguish between shipments of road salt and those of table salt, the report said.

The Institute of Medicine, the nation's most prestigious scientific advisory organization, concluded last year that the agency's system for ensuring the safety of drugs needs an overhaul.

Recent legislation put in place some of the institute's recommendations.

More hearings regarding the FDA's oversight of food are in the offing, including one in the Senate on Tuesday.


</TD></TR></TBODY></TABLE>
As if we don't have enough to worry about!

Kim in CA

janet/FL · 12-06-2007, 12:22 PM

"I was told about Herceptin and heart failure. Everytime I discussed Herceptin...the dr. would shout out the fatal side effects of herceptin...and this was just back in 2005...."

Yep, my "late" oncologist gave me the same song and dance about Herceptin--meanwhile he was very strongly pushing AC!!! As if there were no side affects to them!

Jean · 12-06-2007, 12:43 PM

Kim,
Had no idea that FDA was in such a state! Thanks for this information.This is upsetting - Just recently a very famous
Hollywood personality gave 100 million dollars to a third world
country (which I feel is wonderful ) but it would be nice
and practical if the public (especially high profile persons) would
help raise funds or donate computers to assist programs such as FDA.
It is evident the government cannot keep up.......

Jean

gdpawel · 12-12-2007, 12:07 AM

Here is an example of a cancer trade group and its peer review venue. It is highlighted in a recent video by the Healthcare Channel, questioning a drug's use in breast cancer.

http://blogs.wsj.com/health/2007/12/11/avastin-for-breast-cancer-the-pre-history/

The idea that approving drugs based on population studies has its limits. What may or may not work for the average population may not apply to the individual. Avastin killed more patients than the control arm. Avastin doesn’t have to be used in every breast cancer patient. Taxol doesn’t have to be used in every breast cancer patient (it seems like they do).

The clinical trial was done using Avastin in combination with Taxol. Doctors are faced with a problem of whether to use Taxol and forgo Avastin, or to use some other conventional drug for initial therapy in order to use Avastin.

Avastin is a “large molecule” monoclonal antibody. It can be tested with a EGFR biomarker assay because the “target” of Avastin is not the cells themselves, but rather a hormone (VEGF) secreted by the tumor cells. Avastin complexes with free VEGF and blocks its action.

Having a good tumor-drug match not only would improve survival rates, it would be cost-effective, and the high cost of the newer cancer therapies reinforces the necessity of choosing the right therapy the first time around.

The tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing the individual properties of each patients’ cancer.

http://www.cancermonthly.com/iNP/view.asp?ID=209

SoCalGal · 12-12-2007, 09:45 AM

Wow - scary video - thanks for the link. Hard to know WHAT or WHOM to believe.

Sheila - I thought that avastin was about $1600.00 - $2000.00 every 3 weeks. I know it goes by body weight so maybe I'll lay off those chocolate covered bananas

I am waiting for after San Antonio to figure the Avastin out.
Regards!
Flori

gdpawel · 12-12-2007, 10:10 AM

A recent article published by the NIH concluded that about one fourth of abstracts at ASCO Annual Meetings have an author with a personal financial interest. Since many of these abstracts are about the results of clinical studies, this means that the study results are being penned by authors that may have a personal financial interest in the outcome.

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=1 7704409&ordinalpos=1&itool=EntrezSystem2.PEntrez.P ubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Another article touches upon the attitudes toward research participation and investigator conflicts of interest among advanced cancer patients participating in early phase clinical trials.

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=1 7687154&ordinalpos=2&itool=EntrezSystem2.PEntrez.P ubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

These two articles touch on a critical subject - when an oncologist recommends a treatment the reason behind the recommendation may be complex. It can be a result of the doctor's training and experience in combination with the investments made by the hospital or the doctors own research interests or their financial relationships with various outside entities. In short, a patient and their family must be their own best advocate and get at the heart as to why a specific treatment regimen is being suggested. Don't be afraid to ask questions to make informed treatment decisions!

Cancer sufferers are taking doses of expensive and potentially toxic treatments that are possibly well in excess of what they need. It would seem that pharmaceutical companies are attracted to studies looking at the maximum tolerated dose of any treatments. It is suggested by some that we make the search for minimum effective doses of these treatments one of the key goals of cancer research.

An increasing number of drug studies are developed through collaborations between academic medical centers and drug companies. In fact, pharmaceutical-industry investment in research exceeds the entire operating budget of the NIH. It is important to understand the influence that industry involvement may have on the nature and direction of cancer research. Studies backed by pharmaceutical companies were significantly more likely to report positive results.

Over the past couple of years, if you watched TV with any regularity, it would have been difficult to miss the direct to consumer advertising that touted the benefits of some drugs over others, especially for patients undergoing treatment for cancer. Even to the point that buses covered with "shrink wrapped" advertising being strategically placed outside major cancer centers for patients and their families to see (EPO anyone?).

Drugmakers are going directly to the consumer at a time when their products are indeed at the margins of evidence-based medicine. On one hand, pharmaceuticals advertise extensively and the advertising is manipulative in the extreme. On the other hand, even NCI-designated cancer centers do this sort of direct to consumer, hard sell advertising. And in cancer medicine, the media advertising is no more misleading than the one-on-one communication which often goes on between a chemotherapy candidate and an oncologist.

More must be spent on analyzing drug data, and the need for larger and more detailed studies to figure out why there is an association between pharmaceutical involvement and positive results.

http://jco.ascopubs.org/cgi/content/full/25/25/e31

Sheila · 12-12-2007, 11:24 AM

Flori
My Avastin is 20,000 every 2 weeks...are they stiffing me on this too???? Some may not remember that I filed a claim against my hospital with the Illinois Attorney General about the price gouging on Herceptin...and they reduced it and back paid for 1 1/2 years to EVERYONE who was on it. But for now, I am off Avastin until the insurance decides what to do...maybe my B/P will calm down as it has really done a number on it! Even with meds it is soaring. I had only a double whammy yesterday...Taxol and Herceptin, no Avastin...my husband took me to the Westin by O'Hare due to all the ice and I spent the night in Chicago so I could catch my early flight to San Antonio....
I'm here and its cold and rainy...but feels warm compared to the ice I left.
May we hear good things here!!!!!

hutchibk · 12-13-2007, 09:38 PM

Just to be sure that everyone is clear, the FDA has not yet declined Avastin for b/c. An FDA advisory panel recommended that the cancer drug Avastin should not be used to treat women with advanced breast cancer, but apparently it was a very close advisory panel vote that many top doctors do not agree with... Dr. Winer spoke a little about it last night here in San Antonio, as he was in the hearing when the vote was taken. He said that was a very interesting hearing and a very close vote and it's not necessarily a slam dunk that the FDA will adopt the panel's recommendation to deny Avastin for b/c. He said to not lose all hope just yet. The FDA is not obligated to follow the recommendations of its advisory panels, but often does. A decision is expected by Feb. 23.

gdpawel · 12-14-2007, 09:56 AM

Very good point to bring up hutchibk. Some fifty percent of cancer drug administration is done off label anyway. There will be physicians who will continue to use Avastin in metastatic breast cancer because there was positive data that makes a difference in their individual patients. Every patient is different but you have to give them the best possible chance with a lot of options. Avastin is another option which has some merit.

Sheila · 12-15-2007, 06:36 AM

Christine and I went to the Genentech advocacy luncheon yesterday and there was much talk about the Avastin...the Dr.s who work for Genentech are basically claiming it is getting a "bad rap" while the advocacy groups are saying this drug needs more trials and testing due to the adverse cardiovascular side effects...they don't want massive women dying from strokes to give them a better outcome on Breast Cancer...it got quite heated...very interesting. I did however find it odd that Genentech listed hypertension and cardiovascular events as a rather low side effect...less than 18%, which they considered low. No mention of nosebleeds....Chrissy and I both laughed as we both sat there last night trying to tame bloody noses.
I did receive the official word while down here that my insurance, BCBS is no longer paying for mine, so i misses my first dose the day i came here!