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?

We can expect Orwellian language from George Soros but unfortunately for cancer patients, the language used by the proponents of rationing is the same as the bureaucrats justifying rationing.  Terms like “significant benefit,” and “sufficient benefit” are the rationer’s lexicon allowing bureaucrats use to limit access and choices for doctors and patients because of the cost of the treatment.  In each case, decisions on life are justified on a “cost-benefit” analysis.

Patients in Great Britain have been subjected to rationing for generations.  In Great Britain’s government-run health care system, treatments for patients are evaluated on the basis of cost.  The Orwellian named government agency that regulates costs and denies treatments for patients is called “NICE” (National Institute for Health and Clinical Excellence), has set a general limit of about $49,000 on the cost of extending life for a year.  If the treatment costs more and only gives patients on average 11 months of life, you are out of luck.

That is why NICE announced it would not pay for breast cancer patients to have access to Avastin.  NICE’s chief executive said, “The evidence for the effectiveness of bevacizumab in prolonging survival was not robust and overall did not show enough of a demonstrable benefit for it to be considered a cost-effective use of NHS resources.”

Without the British accent, these terms are now working their way into the American health care vocabulary.

BUREAUCRATIC CATCH PHRASE  vs. PLAIN ENGLISH

“Significant” or “Sufficient”:  Patient sees progress but not enough to justify the “cost-benefit” ratio set by the government.

“Outweigh the Risks”:  Every drug has risks but this drug costs too much.

“Sufficient Benefits”:  Once again, patient sees progress but not enough for our liking.

Cancer patient advocacy groups, unlike progressive think tanks, are protesting the FDA’s effort to move us toward a British health care model.  Kim Thiboldeaux, the president and CEO of the Cancer Support Community, summed up the threat of the FDA’s actions when she the decision would have a “tremendous impact on reimbursement. We feel strongly that treatment decisions should be a joint decision between a women living with treatment and her treatment team…Limiting the already scarce range of treatment options for women with metastatic breast cancer would have a devastating impact.”

Berwick has championed the British health care system for years proclaiming his outright support of rationing. In 2009, Berwick said, “The decision is not whether or not we will ration care — the decision is whether we will ration with our eyes open.” In a 2008 speech, Berwick proclaimed, “I am romantic about the NHS; I love it. All I need to do to rediscover the romance is to look at health care in my own country.” Of course, the British system openly rations care for the sick and the elderly.

But Berwick ran from those statements like a scalded dog before House members who asked pointed questions about his support for rationing care. When Rep. Tom Price (R-Ga.) asked him whether he supports healthcare rationing, Berwick said, “I abhor rationing.” At another point he said that he spent his whole life fighting rationing, The Hill reports.

Chairman Dave Camp (R-Mich.) asked him whether he was still “in love” with the British healthcare system, Berwick’s response: “There are strengths and weaknesses in every healthcare system in the world. The American healthcare system needs an American solution.”

For fear of stating the obvious, it is clear Berwick was not honest in his testimony.

He cut; ran; ducked; weaved; and twisted his long history of support for a government-run health care system. Worse yet, while the Administration may deny support for rationing, their policies are opening the door to it. Just ask late stage breast cancer patients who have been threatened with the termination of insurance coverage of life-extending drug called Avastin because of cost considerations.

The Food and Drug Administration has proposed to “de-label” the drug, a move that would remove insurance and Medicare coverage for patients. The wealthy would still have access to the drug but everyone else would be forced to mortgage their house to be able to continue to use the drug to save their lives. During consideration of the action, a FDA appointee mentioned the cost of the drug basis for their decision.

Even Berwick’s own department is apparently getting into the act. The office has declared a review of the colon drug Provenge because of its cost.

Republicans should not be buying the snake oil Berwick is selling. The Senate Finance Committee should reject his nomination and should begin to end the initial efforts by our government to ration care for the sick and the elderly.

Federal health authorities are recommending the blockbuster drug Avastin no longer be used to treat breast cancer, saying recent studies failed to show the drug’s original promise to help slow the disease.

The Food and Drug Administration’s decision is supported by many cancer experts but is sure to draw resistance from cancer patients and some doctors who fiercely defend the drug and say it should remain available.

The FDA approved Avastin for breast cancer in 2008 based on studies suggesting it halted the spread of breast cancer for more than five months. But follow-up studies showed that delay lasted no more than three months, and patients suffered dangerous side effects.

Doctors will still be able to prescribe the drug “off-label,” though some insurers may not pay for it.

That last bit gives you the real story. This was about cost-cutting, not medical efficacy as we’ve repeatedly shown. Ironically, at about the same time the FDA was making its decision, the EU ruled to continue recommending Avastin. So, for breast cancer patients, there is more choice in Europe than the US.

Medicare Head Donald Berwick will testify in front of the Senate Finance Committee Wednesday for the first time since President Obama used a recess appointment to put him into place. He’ll be facing down a host of Republicans who objected to his nomination on the grounds that he’s in love with wealth redistribution and Britains National Health Service.

Sens. Pat Roberts (Kan.), Mitch McConnell (Ky.) and John Barrasso (Wyo.) joined forces on the Senate floor shortly after the last vote of the day and urged members to review Berwick’s record before voting on his confirmation. They accused Berwick of promoting health care rationing, especially for older people, and particularly criticized his endorsement of Great Britain’s National Healthcare System (NHS). “Dr. Berwick is a huge fan of … the NHS, a system that relies on rationing health care to hold down costs,” Roberts said. “Dr. Berwick has said, ‘I am a romantic about the NHS; I love it,’ and ‘the NHS is not just a national treasure, it is a global treasure.’”

In case Americans are unaware, the NHS has a terrifyingly active healthcare rationing panel. Originally put in place to reduce healthcare costs, root out bad doctors and useless treatments and ensure that healthcare practices were at their absolute best. Over time, NICE has taken to “reducing costs”by limiting the kinds of treatments British patients are allowed to receive through government healthcare. The Wall Street Journal warned Americans last July about NICE and cost-cutting panels. They cited NICE’s rulings against providing lifesaving breast and stomach cancer drugs, blocking or restricting access to drugs to treat macular degeneration, kidney disease, rheumatoid arthritis, multiple sclerosis and myloma, and NICE’s restrictions on fertility treatments, certain surgical procedures and cervical cancer screenings, all in the name of saving money.

One of the questions Berwick will face will likely be on the subject of IPAB – the Independent Payment Advisory Board – a panel made up of fifteen unelected bureaucrats who will be charged with making drastic cuts to medicare on a yearly basis, likely limiting patient choice for Medicare recipients. The panel’s decisions are unappealable and can only be overturned by a supermajority vote in Congress. Berwick will have to explain how IPAB – termed by Sen. Tom Coburn as a “a government command-and-control bureaucracy that will dictate payment decisions and interfere with the best judgment of physicians and families” – is necessary and beneficial to Medicare patients.

The concern is obviously whether Berwick intends IPAB as a wedge for more serious healthcare rationing. In July, Republicans questioned Berwick for defense of NHS healthcare rationing practices, after news came to light that Berwick made glaring statements in favor of rationing in the healthcare debate, at one point saying that most people in serious pain “just need the morphine and counseling that have been around for centuries.” A White House spokesperson defended Berwick saying that rationing was already rampant in the system and that Berwick merely “wants to see a system in which those decisions are transparent – and that the people who make them are held accountable.”

It’s legitimate to want to know whether Berwick supports the kind of healthcare rationing done by the NHS he claims to admire, and it’s only fair to ask whether the IPAB, charged with cutting costs at the outset, will have no choice but to evolve into NICE as pressure builds to cut further into Medicare. The question of healthcare rationing has always been present in this debate, and those who value having a voice in their healthcare decisions deserve to know what the future holds for their care.

Republicans have a constitutional obligation to get Berwick’s views on the record and appear ready to do so.  Politico reports that Republicans will focus their questioning on five areas including his professed “love” of the British government-run health care system.  Berwick has called the National Health Service – with its rationing of treatment and care – as “one of the greatest health care institutions in human history” and “a global treasure,” once saying that it set an “example” for the United States to follow.

Berwick’s support for rationing lead President Obama to bypass the Senate confirmation process to appoint Berwick to his post.

Not surprisingly, Berwick will argue that ObamaCare does not ration care but the evidence is compounding that is not the case.  The FDA will soon decide whether breast cancer patients will be denied access to the last-stage cancer drug Avastin because of its cost.  Perhaps more to the point, Berwick’s own department is considering whether to deny prostate cancer treatment Provenge because of its cost. See a pattern here?

As long as ObamaCare is the law of the land, the specter of rationing will be a real threat on the American people.  The line in the sand has been drawn.  Should the government begin to ration care because of the cost of the treatment, Americans will be denial cutting edge treatment that has made our system the envy of the world.

The Berwick testimony affords Republicans the opportunity to put a leading rationing proponent on record as to whether breast cancer patients and colon cancer patients should be denied critical care because of the cost of the treatment.  That is the real battleline.

Berkwick’s support for the imposition of a British-style health care system complete with its rationing regime is clear. “The decision is not whether or not we will ration care–the decision is whether we will ration with our eyes open,” Berwick said in a June 2009 interview with Biotechnology Healthcare.

In an interview last June, Dr. Berwick said, “NICE is extremely effective and a conscientious, valuable, and — importantly — knowledge-building system.” He added that NICE has “developed very good and very disciplined, scientifically grounded, policy-connected models for the evaluation of medical treatments from which we ought to learn.” Moments later, the interviewer asked, “So you are saying that the federal CER [Comparative Effectiveness Research] agency should get involved in cost determinations?” Berwick replied, “You can say, ‘Well, we shouldn’t even look.’ But that would be irrational. The social budget is limited.” NICE is the government agency in Britain that rations care on a daily basis. Professor Mike Rawlins, the chairman the British National Institute for Health and Clinical Excellence (NICE) who said: “The question is not whether care is rationed but how.”

Sen. Chuck Grassley and Sen. Orrin Hatch decided to call their own oversight hearing. Berwick was asked to attend twice but never responded to the invitation. Others did testify including Dr. Michael Smith, a board certified specialist in both Internal Medicine and Pediatrics from Wisconsin. Smith outlined the threat and ramifications the health care reform bill will have on doctors and patients:

Mr. Chairman, my fundamental opposition to a government takeover of our health care system stems from the fact that it destroys the doctor patient relationship, encourages non-participatory rationing of medical care and will adversely affect access to care for patients. I will leave the economic discussion of the impact of this bill to others, however I am skeptical there as well. When the government attempts to “bend the cost curve,” as President Obama likes to say, it is seniors, the sick and the weakest segment of our population that will suffer. That is not to say we should not be concerned about waste and fraud. We should. But when government is making decisions about how to cut costs, patients will be harmed. Period. To this I can already provide examples. Prior history has demonstrated that rapid changes in the reimbursement to hospitals have resulted in higher post surgical mortality, something none of us want to see again.

Smith also highlighted the outrage that a trillion dollar health care plan was being implemented by a supporter of the British Health care system and was never even subjected to a hearing:

Besides Social Security, there is no position in government that has a bigger impact on America’s seniors than Medicare and Medicaid. President Obama has appointed passionate rationing advocate and defender Dr. Donald Berwick to head the head the Centers for Medicare and Medicaid Services. This is a potentially ominous sign for every senior or near senior in America. Berwick’s nomination was so controversial that the Senate never approved it. His views were never even subject to a Senate hearing I don’t need to tell you that, you would have been talking to him. Ignoring the advice and consent responsibilities of the Senate, the president gave Berwick a recess appointment. Berwick is running an $803 billion agency – and will be responsible for implementing another $500 billion in funds from the new health care law – without Senate confirmation.

Sen. Grassley and Hatch deserve kudos for trying to bring some sanity to the debate. We look forward to more hearings, especially if Republicans manage to gain a majority in the Senate this November.

The simple truth is: You can’t get something for nothing and someone has the pay the bill.  Nothing in Obamacare creates more health care. It is merely injects government into the equation in order to take what we have currently and redistribute it.  So naturally, the government will need to find ways to cut costs.

Soon to be former director of the OMB, Peter Orzag believes that we can save money “…if costly new medical services were adopted more selectively in the future than they have been in the past, and if the diffusion of existing costly services was slowed. “

Well, how does the government go about doing that? How do they tell people that a life saving or life extending treatment exists, but it just costs too much so patients can’t have it?

Well, they don’t. They utilize control over the system to manipulate the availability of the treatment and then lead people to believe that it just doesn’t work. Problem solved.

We’ve already begun to see this operation in action with the FDA’s recent attempts to de-label the cancer drug Avastin for use with Stage 4 breast cancer patients.

The FDA was created and designed to protect citizens from products that are inherently unsafe or that make claims of effectiveness that cannot be substantiated.  There is no authority to consider drug pricing when evaluating a drug.

There is no debate that patients who have taken the drug enjoy an extended life span.  The FDA even admits that the average time with tumor progression on the drug is nearly six months and that follow-up studies have shown no new side effects.

So in the case of Avastin, cost is clearly the factor leading them to consider de-labeling.

The bottom line is that pricing will soon become a key if not determining factor into whether a drug is covered all in an effort to “lower the cost of health care.”

And the FDA will be a crucial skirt behind which weak-kneed politicians will hide.

While Senator Reid believes that people will like the new law once they learn more about it, we beg to differ.  Quite the contrary — the more people know about what’s in the bill the more they don’t like it.  Missouri is showing us the way to fight back.