Posted on 02/26/2011 6:13:45 AM PST by Kaslin
Influenced by the president’s mandate to “bend the health care cost curve,” the Food and Drug Administration (FDA) is preparing to deny late-stage breast cancer patients access to the critical, but expensive, life-extending drug Avastin. The FDA wants to “de-label” the drug, a move that would force patients with insurance or Medicare coverage to pay for the drug out of their own pocket in order to survive. Now patients groups are speaking out.
Led by the Susan B. Komen Foundation for a Cure, 15 patient advocacy groups have petitioned the FDA to reverse their effort to ration the drug. In a letter to the FDA, Elizabeth Thompson, the organization’s President, expresses concern over the potential negative impact that the FDA’s decision will have on women who are benefiting from Avastin:
"We know that for some number of women, Avastin works and works well. We have heard from women who are gaining not just months, but years with a high quality of life, from this treatment.
We are concerned about the potential impact on women who are benefiting from Avastin if the FDA ultimately removes its approval for the drug for metastatic breast cancer treatment. We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, and that their insurers will continue to pay for it...
Today, the issue is Avastin. In the coming years, there will be other treatments that may be controversial but will help some number of women and men with breast cancer live longer, high quality lives, and perhaps to ‘beat’ breast cancer altogether…[w]e must make it possible for these treatments to be available to all who will benefit from them. The decision on Avastin is precedent setting and deserves to be considered in a public setting."
The Avastin case is the rationing camel nose under America’s health care tent. Should the FDA successfully introduce cost into the drug approval process, the long-term implications will be enormous. It will not be breast cancer patients alone who will suffer. Avastin is first step on the slippery slope toward rationing. The FDA’s action is dangerous and cannot stand.
Fortunately, Judge Vinson’s ruling that ObamaCare is unconstitutional has temporarily given hope that we may reverse course before it is too late. While Vinson’s decision finds Obamacare’s individual mandate unconstitutional, it strikes down the entire law as the mandate is not severable from the full legislation.
Like the individual mandate, FDA rationing is a flawed (some might say lazy, dishonest, or inhumane) attempt to lower Obamacare’s alarming financial cost. But both come with heavy price tags, nonetheless. While the mandate will cost jobs and wages, FDA rationing will cost lives that could otherwise be extended, improved, or even saved. We simply cannot afford the real cost of ObamaCare.
Vinson’s decision makes clear ObamaCare implementation by state and federal officials should immediately cease. The Cato Institute’s Mike Cannon and Ilya Shapiro, in a devastating column in the Providence Journal note:
"In ruling as he did, Judge Vinson wrote that “it must be presumed that federal officers will adhere to the law as declared by the court.” Yet the Obama administration has thus far shown no inclination to do so. But neither has it sought to stay the practical effects of the ruling — perhaps because it thinks that doing so would give credence to the court’s decision."
Sadly, the Obama Administration appears to be making calls out of President Andrew Jackson’s playbook. America’s seventh President reportedly once said about a Supreme Court ruling that Georgia could not impose its laws upon Cherokee tribal lands, "John Marshall has made his decision, now let him enforce it!"
Rather than adhering to Judge Vinson’s ruling or request a stay, the Obama Administration is instead requesting a ‘clarification’ of the decision, a thinly veiled attempt to run interference for ObamaCare’s supporters to continue moving forward with implementation of the law. Like its attempts to use the Environmental Protection Agency to bypass Congress in issuing politically unpalatable energy and environmental regulations, the Administration is showing a blatant disregard for the Constitutional separation of powers in ignoring Judge Vinson’s ruling.
Even with Vinson’s decision, the fight is not over and ObamaCare advocates may ultimately prevail, FDA health care rationing and all. The case is expected to move to the 11th Circuit Court by this summer. Efforts are even underway to expedite consideration by the Supreme Court. Until, then, however, it is clear ObamaCare implementation must be put on hold. We do still live in a nation of laws, after all.
Mr. President, Judge Vinson has made his decision, now you have to enforce it!
bttt
At a cost of up to $100k per year noone will pay for Avastin out of their own pockets.
I find these stories ridiculous. Obama Care begins in 2013 so this is propaganda. The very thing we hate. Plus the House has not even given a dime towards Obama care yet and hopefully they won’t.
DEATH PANELS
As soon as patent protection runs out, generics are available at substantial discounts.
If we circumvent this natural progression, the drug will be very expensive forever.
You don’t think the federally controlled FDA isn’t starting to make decisions to ‘bend the cost curve’ to lower federal spending on health care? This happens in every nation where the government both pays for health services and controls supply.
True,but I did enjoy the “family jewels” commerical for
Valentines Day.
The objective is not to deny women this lifesaving drug, but to pick and choose who gets it.
There is no doubt that giving a private company too much power can result in a bad situation.
What the naive believers in Big Government Socialism do not understand is that giving too much power to a Government is far worse.
The answer is finding the right system of Checks and Balances and not swinging from one power extreme to the other.
Something useful the Komen Foundation could do with all that money they raise.
Medicare is only underfunded long term by $72 Trillion or so.
How could this be?
/sarc
“if you had a prescription for it”
maybe you won’t find a doctor who will go against the FDA and the uS govt and write a prescription for it, will you?
Obamacare makes it very very hard for a doctor to buck the system. It attempts to make aggressive medical care for some patients a “bad” thing. Eventually, the obamites will succeed in making most of society accept that people who want to live and whose care is very expensive- are “selfish”
Ironically this drug Avastatin is effective against other types of cancer such as colon and prostate- will it continue to be prescribed for them but not breast cancer?
the government studies and recommendations that will be used to justify obamacare rationing are already being ublished and used as industry standards for determining levels of patient care that are to be covered, ie the Govt study that decided women under 40 do not "need" mammograms nor should women even be doing breast self-exams! How many health plans now deny routine mammograms to women under 40?
I know my own spouse who just entered MEDICARE at age 65 got ONE physical exam at program entry and is not entitled to covergae for any more routine physical exams! This just boggle the senses that "good medicine" now decrees that people over 65 should NOT be covered for annual physicals by their paid-for govt health plan. All our lives we've been advised to get an annual check up! Now all of a sudden it's not necessary.
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