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The Wall Street Journal: "The FDA rigs the verdict against a good cancer drug."

Last week I wrote a post about the FDA considering revoking its approval of Avastin for treatment of metastasized breast cancer, in which I wrote this:

We didn't even have to wait until 2014 for ObamaCare to be fully implemented to see these death panels. Already the FDA is considering revoking its approval for Avastin as a treatment for women with advanced breast cancer because of issues with the drug's cost. Determining whether a drug is or is not too expensive isn't in the FDA's purview. It's job is to make sure the drugs are safe and effective.

Liberal commenters immediately came out of the woodwork to defend the FDA's decision by arguing what the FDA did, that the drug wasn't helping enough women with breast cancer to justify its cost.

Enter the Wall Street Journal, which wrote about the controversy on Friday and provided a lot more information about the research that went into Avastin's use for breast cancer and the FDA's response. It found that the FDA moved the goal posts when it came to approving Avastin for breast cancer:

The FDA later unilaterally redefined its regulatory expectations, devising a pretext to undermine Avastin. The terms of ODAC debate are set by instructions from FDA staff reviewers, and in round two they suddenly emphasized topics that had been resolved in round one, such as the lack of overall survival benefits and safety issues such as toxic side effects.

The latter can include severe bleeding and other life-threatening complications, though they are manageable. Some 812,000 patients world-wide have been treated with Avastin, 90,000 with metastatic breast cancer, and its safety characteristics are well understood. As for survival, Avastin hasn't been shown to extend life on average--but it doesn't impair it on average either, even as patients are enduring the savagery of traditional chemotherapy.

ODAC chairman Wyndham Wilson, a National Cancer Institute lymphoma specialist, conceded that Avastin's side effects only affect "small numbers," but "if you're the one, that's not what you want to be exposed to." But what if you're "the one" for whom Avastin offers massive breast cancer relief, or a reprieve of a few months at the end of life?


Few of the Avastin panelists had any first-hand clinical experience with metastatic breast cancer. Six of the 13 members sat on the ODAC panel that judged Avastin in 2007 and five of them were invited back by the FDA on an ad hoc basis as "temporary members." They ought to have recused themselves if only to preserve the appearance of impartiality.

One of them was Natalie Compagni Portis, a member of the original panel and amazingly enough its "patient representative." She said, "Hope is very important. But to offer hope that isn't substantiated I don't think is responsible." Jean Grem of the University of Nebraska explained her anti-Avastin vote by observing, "We aren't supposed to talk about cost, but that's another issue."

So here we have government-anointed medical patriarchs substituting their own subjective view of Avastin's risks and costs for the value that doctors and patients recognize. If Avastin is rescinded, thousands of dying women will lose more than proverbial false hope in the time they have left. They will lose a genuinely useful medicine.

Read all of the Wall Street Journal's piece. It shows that the FDA's and ODAC's motives aren't as pure as they would like you to believe.

Hat tip: Althouse via The Anchoress


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Comments (14)

Maybe money is the motive? ... (Below threshold)
Nine Fourteen:

Maybe money is the motive? Damn dirty hippie's.

Could it be that this is al... (Below threshold)

Could it be that this is also a way to reduce the drain on Social Security and Medicare? After all, the ultimate goal is "to bend the cost curve downward". Liberals are famous for believing that the end justifies the means. Speeding up the demise of the 'baby boomers' would solve a lot of financial issues for the government..

GarandFan...exactly! The O... (Below threshold)

GarandFan...exactly! The Obama Regime's schemes rely on FEWER Social Security recipients...and thus fewer Medicare patients as well.

The ONLY way the massive and growing unfunded liabilities go away is if the PEOPLE they're based on go away first!

Maybe heh heh, Sarah knew w... (Below threshold)
Nine Fourteen:

Maybe heh heh, Sarah knew what she was talking about with "DEATH PANELS".

As GarandFan said. Thin out the crop of recipients and the dems have even more stolen funds to run socialist BarryCare. Although as a caveat, you can bet the Turbins, Kerrys, Kennedys and so fourth will not be placed in the same camp as joe the plumber when it comes to pulling the plug on granny or not.

Given Barry's statement abo... (Below threshold)

Given Barry's statement about the cost of his grandmothers hip replacement, even though she was dying of cancer; wonder what he thought of all the "costs" associated with prolonging the life of Splash Kennedy? Or was that somehow "different"? You know, "nuance".

Some people are just worth... (Below threshold)

Some people are just worth saving, and the rest of the rabble can just die. We ain't spending money on the riff raff. LORD save us from the crazy left.

One of them was Natalie Com... (Below threshold)

One of them was Natalie Compagni Portis, a member of the original panel and amazingly enough its "patient representative." She said, "Hope is very important. But to offer hope that isn't substantiated I don't think is responsible."

Boy, is this irony. Remember "Hope and Change". Now we have 'hope that isn't substantiated'. Yep, that basically describes the Obama administration itself.

Sadly, this is not the firs... (Below threshold)

Sadly, this is not the first time and it won't be the last that the Food and Drug Administration (FDA) has declined to approve of life saving drugs that do work without the dangerous side effects and the ones that don't work and kill people are instantly approved. This also includes over the counter drugs that have been used for centuries without any side effects at all. The life saving drugs aren't welcome in the medical establishment, namely the American Medical Association (AMA). The doctors that belong to this group are afraid that these drugs with ruin their profit margin and kickbacks from the drug companies, that are cahoots with them. As another commenter stated, it is all about money and it always has been.

Alan Grayson (D): "Republi... (Below threshold)

Alan Grayson (D): "Republicans do not want you to have insurance, they want you to die quickly."

Facts do not lie, liberals do.

*cough* *cough* Death Panel... (Below threshold)

*cough* *cough* Death Panels *cough*

Didn't the initial news sto... (Below threshold)

Didn't the initial news story on this claim that only about 8500 patients have been treated with this??? I gotta go look it up. That is a huge difference from those stated in the WSJ article.

At some point people are si... (Below threshold)

At some point people are simply going to get fed up and start burning down buildings full of paper pushers and bean counters - the sort that have the nerve to tell them that they can't use a treatment because it "costs too much".

Liberal commenters immed... (Below threshold)

Liberal commenters immediately came out of the woodwork to defend the FDA's decision

Read that post again. The most vociferous critics of the drug (and ergo supporters of the FDA's decision) were your conservative regulars, including at least a couple who appear to be doctors.

Nice try.

KimThis is from th... (Below threshold)
Alfonso Paulista:


This is from the WSJ article and actually quoted by you above:

"Avastin hasn't been shown to extend life on average"

There's maybe a debate to be had about whether the FDA should be banning use of the drug, but any honest argument has nothing to do with "Death Panels."






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