From AFP:

US health officials on Friday revoked the authorization of Roche’s Avastin for breast cancer treatment, saying it concluded the drug had “not been shown to be safe and effective for that use.”

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On June 28^th and 29^th in Silver Spring, Maryland, cancer patients and their families will gather in protest of the Food and Drug Administration’s (FDA) effort to ration the late-stage breast cancer drug Avastin.  These patients credit the drug for extending their lives well beyond what was to be expected.

Unfortunately for patients, the FDA has adopted a Marxist position on the issue – not Karl Marx but Groucho Marx.  Groucho Marx once quipped, “who are you going to believe me or your lying eyes?”

Supporters of the FDA’s proposal to limit access to the drug to those who can pay for it out of pocket, argue that since the drug does not affect all patients the same way, the government should save health care costs by moving to deny insurance coverage.  That is the basis of rationing and the basis of ObamaCare.

The FDA and their apologists like oncologist Fred Tucker, who took to the New York Times to defend the agency, argue the law of averages ignoring the reality that some patients respond better than others.  Greg Conko brilliantly responded to their arguments at OpenMarkets.org in an article entitled “The Medium is not the Message.”

Conko retorted:

Technocrats, including Dr. Tucker, have applauded the decision, arguing that Avastin doesn’t work very well, and that it has significant side effects. On the other side are patient advocates and thousands of women who have benefited from the drug, who argue that it’s unfair for the agency to take away an option for patients who are at risk of dying. ”We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it,” said Elizabeth Thompson, president of Susan G. Komen for the Cure. The real question ought to be, who gets to decide?

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It’s not often that the outcome of a protest could be a life or death decision, but that is the position that thousands of women with breast cancer find themselves thanks to a proposal by the Food and Drug Administration (FDA) to limit access to the drug Avastin only to those who can afford to pay for it out of their own pocket.

Not many can.

There are thousands of women who rely on the drug for their survival. Without it, they will die. That fact has prompted a small businessman from Michigan to put his life on hold to fight “the man.” In this case, “the man” is the bureaucrats at the FDA who are on a mission to cut health care costs. If their proposal to “de-label” Avastin becomes reality, Medicare and private insurance companies will no longer have to cover the cost of the drug. In the eyes of ObamaCare proponents – society wins.

But families lose. In fact, the impact on families will be devastating – a death sentence says Terry Kalley, the husband of a breast cancer patient who relies on Avastin to live.

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Conservatives looking to balance the federal budget know the importance of reining in the cost of Medicare. But how you reduce the cost of the program is almost as important as whether you reduce the cost. The implications are enormous and here is why.

Burke Balch, the Director of the Powell Center for Medical Ethics, has done extensive research into the intricate connection of policy provisions contained in the ObamaCare legislation that all lead America down the road to rationing. Balch sees three avenues to rationing, with the primary danger coming from the creation of the new Independent Payment Advisory Board (IPAB).

In the State of the Union speech, President Obama said of what people are allowed to spend on health care, “The health insurance law we passed last year will slow these rising costs.” And he called for “further reducing health care costs.”

As Balch notes, What Obama didn’t mention was how the Obama health care law will “slow . . . rising costs.” It will do so in large part by forcing doctors and other health care providers to limit care, through “quality and efficiency” standards imposed on them that will establish one uniform national standard of care for what treatment may – and may not – be offered patients. Beginning in 2015, these “quality and efficiency” standards will be drawn from recommendations of an 18-member Independent Payment Advisory Board that is directed to come up with ways to limit what private citizens choose to pay, using their own funds and private insurance, so that they cannot keep up with the rate of medical inflation.

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Drug A is approved by the Food and Drug Administration to treat a disease.

Drug B is not.

Drug A is proven effective to treat a serious disease.

Drug B is not.

Drug A is proven safe.

When Drug B is taken scientists report a higher rate of “serious systematic events” when it is taken.

If you are a government bureaucrat which drug do you recommend a patient take?

If you are an Obama ideologue driven by a desire to limit the cost of health care, you choose Drug B.

This is not a theoretical example but is the new reality of “comparative effectiveness,” a cornerstone of the president’s health care initative where cost trumps everything. The cheaper the cost, the more the government will push a drug despite safety consquences.

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In the days before ObamaCare, there was a clear delineation between the American medical industry and the government.  The industry would invest – often with the assistance of government policy initiatives — in finding cures and the government would ensure the new drugs were safe.  It was a simple equation that worked and helped make American medicine the envy of the world.

Since the election of President Obama and the enactment of his government takeover of our health care system, the emphasis is no longer on finding cures but limiting cost.  In fact, limiting cost is taking precedent over protecting the safety of patients.

The foundation of this effort was laid in the president’s ill-fated stimulus plan.  A provision in the bill set aside over $1 billion for “comparative effectiveness” research – certainly a “shovel ready project” if we every saw one – but that is a debate for a different day.  Betsy McCaughey of the Hudson Institute warned that the provisions “treats health care the way European governments do: as a cost problem instead of a growth industry.” Rep. Charles Boustany Jr., (R-LA) a heart surgeon, warned that it would lead to “denying seniors and the disabled lifesaving care.”  Sen. Jon Kyl (R-AZ) unsuccessfully proposed amendments to bar the federal government from using the research to eliminate treatments for the elderly or deny care based on age.  How right they were.

The National Institute of Health will release their first high profile multi-million study next week to determine whether the drug Avastin (the same drug the Food and Drug Administration is trying to deny to breast cancer patients) can be injected into the eye to combat wet age related macular degeneration instead of the FDA approved drug Lucentis.  Avastin was never approved for this purpose but the cost of Avastin is cheaper than the cost of Lucentis.

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The most instructive part of the president’s “deficit” speech last week was his insistence that he could help balance the budget through an “independent commission” with the “authority to make additional savings by further improving Medicare.”  That commission is the Independent Payment Advisory Board (IPAB) and it is nothing more than another leg in ObamaCare’s rationing stool.

Writing in the Weekly Standard, Mark Hemmingway writes:

Here’s how IPAB works. It’s a panel comprised of 15 presidential appointees who are tasked with reducing Medicare spending. The panel is is given certain spending targets that kick in in 2014. At first those targets are on a sliding scale, but by 2018 the spending targets are set at the rate of GDP growth with an additional half of a percentage point tacked on. (Originally, it was GDP plus a full percentage point, but according to the “framework” released prior to the President’s speech the spending target has been reduced.)

Any recommendations IPAB makes about Medicare spending automatically become law. Congress can only override IPAB with a three-fifths majority vote, which is a very high legislative hurdle, or they can pass their own Medicare plan that meets the same spending target. There’s no administrative process for doctors or citizens to challenge the board’s decisions. There’s a school of thought that says IPAB is even more blatantly unconstitutional than the individual mandate, as its power sounds legislative in nature — its declarations would have the force of law — and therefore cannot legitimately be delegated to an executive entity.

In short, the IPAB would give power to unelected bureaucrats the make life or death decisions about Medicare – and probably private insurance – coverage without any way for patients to challenge the decision of the board.  Rationing would be implemented without a vote of Congress.

Writing in the National Review, James Capretta, points out that the Administration will not only use the panel to ration care but it’s real purpose is to build a stepping stone toward a nationalized health care system.

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Senator Jon Kyl and a group of Senators – including Sens. Mitch McConnell (Ky.), John Barrasso (R-Wyo.), Tom Coburn (R-Okla.), Mike Crapo (R-Idaho), and Pat Roberts (R-Kan.) have introduced critical legislation that seeks to protect the doctor and patient relationship from the oncoming onslaught of ObamaCare.

Known as the PATIENTS Act, the bill works to protect the individualized relationship between doctors and patients ensuring that new government rules and mandates that put a premium on cost never interfere with the practice of quality medicine.

To better understand how that will happen if ObamaCare is not defunded or repealed, it is critical to understand the nature of “comparative effectiveness research.” In order to save money for the cost of socialist health care regimes, bureaucrats often play the “comparative effectiveness research” card to mandate that doctors provide inferior care and treatment that often does not work.

These studies, for which there is nearly a billion dollars worth of funding in the ObamaCare bill, become the basis of bureaucratic mandates that substitute the government’s judgment for that of a doctor. For instance, if a government study says that drug X is as effective as drug Y (which is cheaper), the government will often begin to deny coverage for drug X forcing the doctor to use drug Y. In some instances, patients only respond to drug X. Doctors and patients should never be forced to take drugs that don’t work. Doctor’s need to be able to make these decisions without interference from a bureaucrat. That is what the Kyl bill seeks.

This is not a theoretical argument any longer.

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It’s hard not to imagine that some bureaucrats that the National Institute’s of Health were not thinking of Robert Burns’ “best laid plans of mice and men” when they heard the results of a recent “comparative effectiveness” study of the drugs Lucentis and Avastin.

“Comparative effectiveness” studies are the shoehorn for government interference between the doctor/patient relationship. These studies allow bureaucrats to dictate health care decisions that should be made by doctors by determining that certain drugs or treatments are comparable and the cheaper drug becomes the one the government covers for treatment. The ObamaCare takeover of our health care system appropriated nearly $1 billion for these studies.

The National Institute for Health (NIH) initiated a study into the “comparative effectiveness” of the drugs Lucentis and Avastin – both made by the same manufacture. The basis of the study was to determine whether Avastin could be used as a substitute for Lucentis when treated macular degeneration. Avastin was never approved by the FDA for macular degeneration while Lucentis was tried, tested and approved for such purpose.

The initial test results showed the danger of such a strategy.

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Senator Jon Kyl (R-AZ) has introduced critical legislation that aims to stem the coming tide of rationing of America’s health care services. The PATIENT’s Act will ensure doctors and patients have the final say about medical treatment and new ObamaCare created “comparative effectiveness research” will not put a government created barrier to better treatment.

On the surface, there is nothing inherently wrong with “comparative effectiveness research.” Advocates believe it will save the taxpayers money by studying whether alternative and cheaper treatments are just as effective as currently prescribed methods of treatment. ObamaCare appropriated nearly $1 billion for such studies.

The problem, however, is when government takes that research and mandates a “one-size-fits-all” health care regimen that does not fit every patient . And with government mandated to reduce the cost of health care, these studies will assuredly become the intellectual justification of rationing. Here’s why.

Doctors have a unique relationship with their patients. They know how they respond to treatments. Government bureaucrats do not know, and frankly do not care, how an individual responds. They care about the big picture – the bottom line. If they can show cost savings by swapping a drug, they will do it. That appears to be happening with the drugs Lucentis and Avastin.

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As breast cancer patients anxiously await a June Food and Drug Administration (FDA) hearing to determine whether they will continue to have access to the life-saving drug Avastin, members of Congress are standing up for patients. Most notably Sen. David Vitter in the Senate and Rep. Kay Granger in the House, and now Rep. Alan Nunnelee, have recognized the dangerous precedent of the Avastin case. Including costs in the evaluation process will limit access of drugs to patients, interfere with the doctor/patient relationship and start American down the road to rationing.

Avastin is an (expensive) anti-cancer drug that has been proven to extend the life of patients. Some unfortunately do not see great gains – perhaps only a few months – while others live for years, crediting the drug for their survival. The FDA is attempting to “de-label” the drug, meaning the drug would be available if you could afford to pay for the drug out of your own pocket. Insurance and Medicare would no longer assist patients in paying for the drug.

At a House Appropriations Subcommittee hearing, Granger raised her concerns about the pending Avastin decision directly to the Secretary of Health and Human Services, Kathleen Sebelius. Granger pointed out that patients and doctors in her district have alerted her to the decision and believe having the Avastin option is a critical tool in fighting breast cancer. Granger pressed Sebelius to assure seniors that Medicare would continue to allow doctors the choice of prescribing Avastin and cover its costs. Sebelius could not or would not. Should the FDA move forward, cancer patients will be on their own – the first victims of the effort to “bend the health care cost curve.”

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The socialists and rationers at the European Union appear to be more sensitive to the plight of breast cancer patients that the Food and Drug Administration (FDA) seeking to implement President Obama’s mandate to “reduce the cost of health care.”

In June 2010, a subpanel at the FDA recommended that the late-stage cancer drug Avastin be denied insurance and Medicare coverage for breast cancer patients.  Cost was specifically mentioned as a reason for the decision.  “De-labeling” the drug will save Medicare the burden of paying for the drug that can run $80,000 a year.

Despite protests from thousands of breast cancer patients who cannot afford the treatment without insurance, the FDA approved the panel’s recommendation in December.  Patient groups like Susan B. Komen and Cancer101 have now entered the ring arguing that decision – if it becomes final – will have dramatic implications for the future of our health care system.  They are pleading for the FDA to reverse itself.

Now the European Union health care advisory committee– a bastion of socialist medicine and open rationing of care – has found that Avastin in combination with chemotherapy helps women with metastatic breast cancer live longer without their disease worsening.  That is exactly what American cancer patients and doctors have said all along.

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The Food and Drug Administration (FDA) is moving to “de-label” Avastin, the late-stage cancer drug for breast cancer patients. If successful, the FDA would allow Medicare and private insurance to deny coverage for the drug – even for patients who have relied on the drug to live.

The FDA has denied that the cost of the drug played a role in their decision but the evidence is mounting that is not the case.  During initial consideration of the decision an FDA advisor specifically cited the cost of the drug as the reason for revocation.  The drug costs $80,000 a year and allowing Medicare to deny coverage for the cost would “reduce the cost of health care,” as President Obama has demanded.

The FDA and their supporters deny cost is the basis of the decision.  George Soros’ Media Matters denounced the rationing claim proclaiming that the drug does not “does not significantly prolong life.”

Significantly? Is six months, the average time an Avastin patient gets in extended life, “significant”?  Is one year?  What about the cases of the “super responders,” the women like Erin Howarth, who have taken Avastin for years and credit the drug for saving their life?

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The cancer drug Avastin has become ground zero in the debate of the future of our health care system. Will drugs and treatments be rationed under a government-run system? Will patients have the same access and options as they do under our current plan? Will patients be subject to a “cost-benefit” analysis by government bureaucrats – like in other countries — when deciding what drugs the government will cover and what drugs they won’t?

Recent actions by the Food and Drug Administration (FDA) to “de-label” the late stage cancer drug raise these and other issues critical to the future of our health care system. The FDA proposal would essentially allow Medicare and other insurance plans, including private ones – to tell patients they will need to cover the cost of the treatment on their own. There would no longer be an obligation to pay for treatment. If you want Avastin as an option in your efforts to fight breast cancer, you would have to pay for it. And what if you cannot afford the estimated $80,000 a year for treatment? The FDA won’t answer that question.

The maker of the drug has petitioned the FDA for a hearing on their actions and have yet to be granted even the ability to make their case. But they have strong advocates in their corner, including a number of influential patient advocacy groups that fear the FDA’s decision will limit patient and doctors choices in the future.

Among those that have critically weighed in against the FDA include the Susan Komen Foundation, Cancer101, the Colon Cancer Alliance and the Cancer Support Community. They understand the stakes and see the decision as a critical precedent that will change our health care system dramatically – and not for the better — if the FDA moves forward.

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The recent ruling by a federal judge invalidating Obamacare in its entirety was a resounding victory for opponents of the sweeping law. It isn’t though, by itself, the end of the fight. The final determination of the constitutionality of Obamacare could take months or even years. The efforts to repeal Obamacare can’t simply wait for the courts. Continued action is needed now.

During the recent House vote, only three Democrats voted withRepublicans to repeal ObamaCare – less than the 13 who remain in Congress who opposed the original legislation. Typical of their response was Rep. Larry Kissell (D-NC). Kissell voted against ObamaCare but then voted against its repeal – a tacit endorsement of the legislation.

Kissell told McClatchy News Service that he would rather “chip away” at the legislation.  Okay. The time has come to start chipping.

It’s clear that the repeal vote is essentially the floor. Efforts to “chip away” at the bill will garner more support than the repeal vote, as Kissell and his ilk will vote for Republican efforts to “replace” the bill. Jason Altmire (D-PA) opposed the bill and repeal saying, “We think, by in large, it was a bad bill. It did more harm than good. But to repeal it all, including the few provisions that were beneficial, just doesn’t make sense.”

Let the chipping begin.

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The House of Representatives moved quickly to pass legislation to repeal the President’s Health Care Reform measures but for breast cancer patients, repeal might not come soon enough.

Breast cancer patients are among the initial victims of the ObamaCare mindset where cost of treatment trumps the effectiveness of treatment. Thanks to the Food and Drug Administration (FDA) the life-extending drug Avastin may no longer be an option for breast cancer patients – despite evidence of its effectiveness and testimony of women—and their doctors– who believe they survive solely because of the drug.

The FDA seems intent on “de-lableing” the drug – a move that would allow insurance companies and Medicare to deny coverage for the drug. Even though the FDA is not charged with considering the cost of a drug when determining its availability, it is apparent they did. 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.”

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House Republicans lived up to a primary campaign promise when they voted to repeal ObamaCare by a vote of 245-189, with three Democrats joining the effort. Despite the headlines and congratulatory news releases, the real work is just beginning. Even after the vote, the forces of rationing are still firmly in control of our government and it’s health care policy. The time has come to roll up their sleeves and get creative to find ways to repeal, defund, and delay imposition of the government health care scheme that is in its first stages of implementation.

The government’s mandate to “reverse the health care cost curve” is taking over policy decisions. Rather than mandating “cures” the government is mandating “cost” as the primary driver of our health care policy. As such, patients are being denied access to critical drugs they need to survive. While the vote to repeal ObamaCare is a critical first step, Congress needs to act – and quickly – to save the lives of patients like Christy Turnage.

Turnage is a breast cancer patient who relies on Avastin to survive. The drug is not cheap but Turnage is among a group of “super responders” whose life depends on the availability of the drug. But the FDA has other ideas. Cost, which has never been considered in the approval process, was a factor in the decision whether to “de-label” the drug. De-labeling Avastin and other expensive drugs mean that the rich will have access to it while Medicare patients and those who rely on private insurance will be denied coverage.

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House Republicans lived up to their promise to vote on repeal of ObamaCare and for that we are grateful.  But the roadblocks to enactment of the measure are great.  From the filibuster to a presidential veto, the bill has long odds to become law without another national election.  But Republicans can—and must–turn symbolism into reality by shifting their focus to the individual pieces of the legislation that are most offensive and intrusive.

Individual Mandate:  The House should have an up and down vote on the individual mandate provisions of the legislation.  Time and time again, House Democrats have failed to answer the basic question – where in the Constitution does it authorize the Congress to force individuals to purchase health insurance?  Nancy Pelosi scoffed at the suggestion Congress’ power can be restrained.  Former House Judiciary Chairman John Conyers said there were a “very good set of arguments” for the constitutionality of the mandate but he couldn’t name any.  Rep. John Lewis cited the “pursuit of happiness” language of the Constitution as the basis for its constitutionality.  Of course, “pursuit of happiness” comes from the Declaration of Independence not the Constitution.

Rationing:  Thousands of lives hang in the balance on the FDA’s Avastin decision.  The drug, which extends life of late-stage cancer patients, is about to be “de-labeled” for by the FDA for breast cancer patients because of cost-considerations.  Women who rely on the drug to survive are already starting to see coverage denied even before final FDA action. Democrats have joined Republicans in protesting the FDA’s actions.  Congress should vote up or down on the Avastin decision as well as on legislation to end future rationing of drugs and treatments.

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Shortly after the Food and Drug Administration (FDA) announced it would cut off late-stage breast cancer patients from Avastin, the Obama Administration announced it would create “end of life counseling” program for Medicare patients. How convenient. The government is sentencing women to death but will try to make them feel better about it.

It’s no surprise that the announcement of the creation of “end of life counseling” comes from the rationer-in-chief Donald Berwick — the unconfirmed head of the Office of Medicare and Medicaid Services. Berwick has said that “Cynics beware, I am romantic about the [British] National Health Service, I love it.” Here’s another Berwick quote: “The decision is not whether or not we will ration care, the decision is whether we will ration with our eyes open.”

It’s clear the bureaucrats have begun to ration care with their “eyes open” but the question is the American people seeing what is happening?

For decades, America was not only the golden land of opportunity; it was the place where the sick would come for cutting edge treatments that could not be found anywhere else. The socialist health care systems of Europe could not save your life, but a trip to America often could. Americans took this for granted. But we cannot anymore.

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The reaction to the Food and Drug Administration (FDA) rationing scheme for late-stage cancer drugs has been met with a swift reaction from both sides of the political aisle. Even liberal Democrats who voted to implement ObamaCare have voiced critical objections to the FDA’s denial of Avastin for breast cancer patients. Even the Susan Komen Foundation for a Cure raised concerns.

But one of the more interesting aspects of the FDA’s scheme is the specious claim that Avastin does not work. But on the same day of the ill-advised decision, the FDA’s European counterpart — representing the government-run health care systems in the European Union – issued a statement approving Avastin for metastatic breast cancer concluding that the “benefits continue to outweigh the risks, because the available data have convincingly shown to prolong progression-free survival of breast cancer patients without a negative effect on the overall survival.”

This evidence certainly undercuts the FDA’s claims. Europe’s government-run health care systems openly ration drugs based on cost concerns. The British, for example, have rationed Avastin and admitted the decision was based solely on cost considerations. With a “push-button” rationing system, the fact that the Europeans recognize the benefit of the drug raises further questions about the true reasons for the FDA’s decision to deny patients and doctors access to the drug.

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