Re: OT (?): FDA reverses approval of Avastin on grounds it doesn't provide "sufficient" benefit

"Janet" <boxhill@xxxxxxxxxxxx> wrote in message news:8nih9gFdpeU1@xxxxxxxxxxxxxxxxxxxxx
W. Baker wrote:
Ellen K. <firstinitiallastname@xxxxxxxxxxxxxx> wrote:
The below is an editorial. Regardless of whether one agrees or
disagrees with the opinions expressed, some very thought-worthy
points are raised.

http://www.investors.com/NewsAndAnalysis/Article.aspx?id=557595&p=1

ObamaCare Rationing Begins
Posted 12/22/2010 07:07 PM ET

Medicine: The FDA has reversed its approval of a widely used cancer
drug approved in Europe to treat breast cancer on the grounds it
doesn't provide a "sufficient" benefit. Let the terminally ill and
their doctors decide.

One of the blessings of blocking the omnibus spending bill was that
it included $1 billion for the implementation of ObamaCare.

Yet the first effects are still being felt, the latest being the
Food and Drug Administration's revoking of regulatory approval of
Avastin to treat late-stage breast cancer.

The reason given by the FDA was that the drug does not provide "a
sufficient benefit in slowing disease progression to outweigh the
significant risk to patients." What risk? These women are dying.
The drug buys them precious time, and the only risk they face is
from an FDA saying "pull the plug."

On the same day the FDA channeled Dr. Kevorkian, its European
counterpart, the European Medicines Agency, issued a statement
approving Avastin for metastatic breast cancer.

Benefits of the drug, it said, "continue to outweigh the risks,
because the available data have overwhelmingly shown to prolong
progression-free survival of breast cancer patients without a
negative effect on the overall survival."

So what say you, FDA? An agency overseeing the cost-conscious,
government-run health care systems in the European Union says
Avastin does provide sufficient benefit at little risk to the
patient.
The annual cost, however, is a staggering $88,000 annually, and under
ObamaCare cost trumps medical care. A prime decision is whether
extending your life is worth the cost.

Consider that every year some 17,500 American women are prescribed
Avastin by their practicing oncologists to treat their condition and
prolong their life. Last October, the U.S. National Comprehensive
Cancer Network, a group of 21 leading cancer centers that issues
evidence-based medical guidelines, reaffirmed Avastin's efficacy in
certain cases.

Avastin, the marketing name for the drug bevacizumab, is the world's
best-selling cancer drug. Used primarily to treat colon cancer, it
was first approved by the FDA in 2008 for treating breast cancer
after it was found that by cutting the blood flow to tumors it
slowed the progression of the disease. In some cases it has been
shown to extend life as long as 20 months.

In a joint letter to the FDA and key lawmakers, two organizations -
Susan G. Komen for the Cure and the Ovarian Cancer National
Alliance- urge that Avastin continue to be approved for metastatic
breast cancer patients and warn of the message this "decision sends
about drug development for women with advanced breast cancer."

Breast cancer is the second most common cause of cancer death among
American women, with 40,000 fatalities last year. Komen says the
decision to use Avastin should be made between a woman and her
doctor after a thoughtful consideration of the benefits and risks.
We agree.

Avastin is still available on an off-label basis since it is still
approved for colon, lung, kidney and brain cancer. But insurers are
reluctant to cover drugs that are not FDA-approved. Medicare never
does and the Centers for Medicaid and Medicare Services are now
headed by Dr. Donald Berwick, to whom we and others have referred as
a one-man death panel.

"The decision is not whether or not we will ration care - the
decision is whether we will ration with our eyes open," Berwick has
said. For some that will mean the eyes closing forever.

Berwick has also opined: "We can make a sensible social decision and
say, 'Well, at this point, to have access to a particular additional
benefit (new drug or medical intervention) is so expensive that our
taxpayers have better use for those funds.'"

Like what? Tattoo-removal programs or Formosan subterranean termite
research? This is your government, and it's here to help.

Avastin, when injected into the bosy a a whole(as opposed to a tiny
amount injected into the eyeball, carries risk of severe vascular
events like stroke and heat attack. For most with cancer(It was
originally and still is given for colon cancer at twice the dose for
breaast cancer) the patient considers it a smal price to pay for
possible benefit. I know tht when the first eye tests with Avastin
were run they used intravenous shots and had broblems with blood
pressure rises that were of concrn even though the amounts were far
less than what is used in cancer treatments. When they developed the
tiny dose given intraocularly this risk disappeared for he wet
macular degeneration patients.

I believe tht there was consierable controversy when avastin was first
used for breast cancer and it took Medicare a long time before they
were willing ot pay for it as the data was confusing. It seems that
it does work well for SOME patients and does little or nothing for
others, but has been given generally without tryng to establish who
actually would benefit. Peraps tht would be a fruitful subject for
study so the drig coul dbe prescribed only for those who actually
benefit.

Wendy

Thank you, Wendy, for rational discourse vs right wing propaganda.


I specifically stated at the top of the post that the piece reproduced was an editorial, and specifically recognized that some readers might disagree with the opinion expressed by the writer, but that there were substantive points that deserved attention. I'm sorry you didn't care to address any of the substantive points.

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