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

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
.

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