British cancer patients denied life-saving 'near-label' drugs

Thousands of cancer patients are being denied drugs that could extend their lives because of restrictions on supplying medications outside their licensed use, campaigners say. Almost 3,200 patients have been forced to plead for funding from the NHS for so-called “near-label” treatments – medicines licensed for use in some cancers, but not in other, similar forms of the disease. In the past three years, 1,053 applications for funding were rejected by local primary care trusts (PCTs), meaning that patients had either to go without or pay up to £20,000 for treatment.

The figures, uncovered through Freedom of Information requests to every PCT in England, are published today by the Rarer Cancers Forum. The charity says that the problem arises because the National Institute for Health and Clinical Excellence (Nice), which assesses drugs for NHS use, cannot recommend a treatment outside its licensed use.

After a review of access to cancer treatments last year, Nice promised to speed up its processes and consider the greater value attached to some drugs designed to treat terminal conditions. However, where drugs could be used outside their licensed fields, doctors have to apply to local PCTs for funding to use a drug on a case-by-case basis, generating a postcode lottery of access to the treatments.

Stella Pendleton, executive director of the Rarer Cancers Forum, said: “The NHS is forcing desperate patients into the cruel situation where the chances of their being given the treatment they need depend on where they live. “No patient should be denied a treatment recommended by a doctor simply because the cancer it treats is too rare for the medicine to be licensed. We need these obstacles removed. “Drugs companies, politicians and the NHS have a responsibility to patients to fix this system.”

The Department of Health said: “Doctors can use their clinical judgment to prescribe any treatment that will benefit their patient, even if it is outside its licensed indication. “Such decisions need to be made in discussion with the patient concerned and funding may need to be agreed with the local PCT. “Where NICE guidance is not available, it is only right that local PCTs should continue to make these difficult funding decisions according to the needs of their local population."

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The Health-Care Grail

A public policy debate takes on religious overtones

“I believe that by the end of my first term in office that we will have a universal health-care system instituted in this country. That is a commitment that I’ve made, and it is a commitment I want to be held accountable for.”

The words belong to Barack Obama, and he spoke them in April 2007—the last time he visited Portsmouth, N.H., for a town-hall meeting on health care. The Associated Press reported the crowd that day “was almost single-mindedly focused on a single-payer system.” Candidate Obama asked if they would agree to much higher taxes for such a system. And he emphasized that he would remain open to changes even after he released his plan.

Today, a very different Mr. Obama returns to Portsmouth for another town hall on health care. Gone is the demand that supporters acknowledge the implications of their plans (e.g., higher taxes). Gone too is the openness to good ideas from others. In their place is a my-way-or-the-highway president who impugns the character and motives of dissenters.

In his Saturday radio address, the president characterized opponents as “defenders of the status quo” trafficking in “misleading information” and “outlandish rumors.” His communications officer for health care, Linda Douglass, tells CNN that those who show video clips of Mr. Obama speaking are spreading “disinformation.” And far from scaling back the attacks, the same Obama aide who asked people to forward “fishy” emails critical of the president’s proposals yesterday unveiled a new White House Web site accusing critics of scaring Americans “with half-truths and outright lies.”

Now, at one level the intimation that anyone who questions the president must be a liar probably reflects frustration with the legislative outlook for health-care reform. Nevertheless, it is highly unpresidential. And it suggests that the president and his allies see disagreement over health care as less a political dispute than the trampling of sacred doctrine.

That doctrine begins with the notion that health care is a human right, and that government is the only honest player. Accordingly, any health-care plan must be both universal and guaranteed (read: paid for) by the government. And as long as we’re guaranteeing fundamental rights, let’s throw in abortion—no matter how much it complicates getting the bill through.

Different people have different objections to these proposals, almost all practical. Many loathe the status quo and advance reforms that would make health care more market-friendly and coverage more affordable—especially for the working poor. The questions they ask are likewise grounded in common sense: “What will it cost?” “How will we pay for it?” and “Is the public option a Trojan Horse for a single-payer system, just as Massachusetts Rep. Barney Frank suggests?”

Cost is probably the biggest objection. When Mr. Obama first proposed his overhaul, he justified it on the grounds that it would bring costs down. Now the Congressional Budget Office says costs are likely to go up. So what does the president do? He calls the CBO director onto the Oval Office carpet—a virtually unprecedented White House intrusion into a nonpartisan congressional institution.

“President Obama says that both sides agree we need to lower costs, promote choice and provide coverage for every American,” says Grace-Marie Turner, president of the Galen Institute, a free-market health-care think tank. “But he never confronts the simple fact that the measures he’s supporting achieve none of those goals. Instead of debating, the White House attacks anyone who raises a question.”

Of course, when fundamental human rights are at stake, it seems churlish to worry about little things such as the price tag. Or higher taxes. When it comes to the Holy Grail of universality, liberal intentions are far more important than actual outcomes.

“Think of public education,” says James Capretta, a health-care expert at the Washington-based Ethics and Public Policy Center. “They want to do for health care what they’ve done for education—establish a government-run, universal system. Once in place, they will defend such a system whether or not it delivers the results it promised.”

In his inaugural address, Mr. Obama dinged his predecessor when he asserted that his administration would “restore science to its rightful place.” The implication was unmistakable: In place of rigid religious orthodoxies, Team Obama would be clear, cool and pragmatic.

It turns out that the president has his own orthodoxies. These may owe more to his liberalism than to his faith. But they help explain the tenor of the attacks on those who dare question them—and the growing prospects for a major defeat in Congress on the president’s signature issue.

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The Blue Dog "Forlorn Hope Brigade"

By Robert Romano

Nancy Pelosi does not care if the passage of ObamaCare costs her seats in the House come 2010. She has already done a head count. And she knows exactly how many Blue Dogs and other vulnerable Democrats in that chamber she can spare in 2010 to fully enact her and Barack Obama's radical agenda to quickly implement a government takeover the health care system.

Call them the Blue Dog "Forlorn Hope Brigade." The real Forlorn Hope Brigade was nicknamed after the French army pawns that would always be the first to charge into battle, with little to no hope of survival. They were in essence cannon fodder. But they were told to think of the glory. To know that their sacrifices were for a good cause. And that's the position Pelosi and Obama have put the Blue Dogs into. They are now the sacrificial lambs by which to enact an agenda that is almost alien to the American people. They gave the radicals in the Democrat Party the numbers they needed to achieve a majority in 2006.

And if 30 or so of them must now be sacrificed to achieve that end, then that's just what Pelosi is going to do. They're expendable. Only they have a choice. Which was undoubtedly why 40 Blue Dogs in June signed a letter stating they would not support a plan that was not "deficit-neutral." Barack Obama said that, too, only one hopes that the "Forlorn Hope" actually means it.

Testifying in July the director of the Congressional Budget Office (CBO), Douglas Elmendorf, told the nation that the plan now proposed would not include "the fundamental changes that would be necessary to reduce the trajectory of federal health spending by a significant amount." "On the contrary," he said, "the legislation significantly expands the federal responsibility for health-care." Mr. Elmendorf said the cost curve was being raised instead of cut. Previously, Barack Obama and Democrat leaders had promised to cut the growth in spending of health care programs with their proposal.

In July, Americans for Limited Government President Bill Wilson explained the dynamics involved, "The Blue Dog Democrats realize that there is blood in the water. They are hearing from constituents angry over the $1.8 trillion deficit, the $13 trillion in committed bailouts, the failed, wasteful $787 billion 'stimulus', and the costly cap-and-tax. So, the Dogs know that their political necks are on the line." Wilson added, "The American people do not want government-run socialized medicine. Right now, the Blue Dogs have enough signatories to kill the legislation or, at the very least, slow it down. And if they value their political survival, that's exactly what they will do."

They did slow it down, but now they know that will not save them in the end.

Recently, meeting with El Dorado Tea Party leader John Wilson, Congressman Mike Ross (AR-CD4), a Blue Dog leader, on Wednesday told his constituent that he did not think the final version of the bill would include the contentious public "option"—the mandatory government-run health care currently contained in the bill. Which is funny. Because he already voted for the so-called public "option," in a compromise deal with lawmakers on the House Energy and Commerce Committee. Is he now saying he will not vote for the bill when it comes up again on the floor?

John Wilson does not know, because Ross did not say. "I certainly hope he's right, but what I still want to know is, will he support or oppose having a government-funded 'public option?'" Good question.

The fact is, Ross' silence on the matter is telling. He is, after all, the captain of the Blue Dog "Forlorn Hope Brigade." And now he is simply hoping that he is not going to be sacrificed when in his heart he knows the fateful decision has already been made.

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Auto & Health Insurance: A Just Government Would Mandate Neither

By Victor Morawski. Morawski is a professor of philosophy at Coppin State University

Let me first alert regular readers that I will do two things below uncharacteristic of most center-right writers: agree with Robert Reich and disagree with Rush Limbaugh.

In a pre-election Wall Street Journal article comparing the proposed health care plans of Hillary Clinton and Barack Obama, former Clinton Labor Secretary Robert Reich correctly assessed the controversial nature of government mandates. He observed, "Democrats are leading with their chins…to many Americans…it conjures up a big government bullying people into doing what they'd rather not do." Mr. Reich is, of course, correct, proving anew the old adage, "Even a blind squirrel finds an occasional acorn.

An argument now being used by "Obamacare" proponents to justify their onerous mandates rests on seeing health insurance as analogous to auto insurance. They ask, if government can mandate auto insurance, then why shouldn't it also mandate health insurance? In a response uncharacteristically out-of-sync with his normal defense of individual liberty, Rush Limbaugh challenged the liberals on this point by denying that the analogy holds. Which, of course, is true. He then surprisingly defended government mandated auto insurance while rejecting the same mandates for health insurance. And there, he went askew.

Government is justified in mandating auto insurance, he reasoned, because it does so not primarily to protect you, the insured, but the other driver. You buy health insurance, on the other hand, he averred, to protect yourself. And, as this is the case, government should stay out of your decision whether to do so.

This response plays right into the hands of the nanny staters arguing for mandated health insurance. To claim that the good of others in society morally justifies government mandating auto insurance leaves one little response to the liberal argument that it also for the good of others in society that health insurance be mandated for all.

In short, the left proclaims, you should have a binding legal – rather than elective moral – obligation to "love thy neighbor." And that is quite simply an operational definition of "poppycock."

The philosopher Immanuel Kant argued rather persuasively that it is morally wrong for a society to use one person as a mere means to the achievement of an end rewarding a second person, especially if such use meant overriding the free choices of the person used. In the current Obamacare scenario, this would mean that imposing government mandates to purchase health insurance on uninsured members of society because it promotes the common good by lowering everyone's health insurance premiums uses these uninsured persons as a mere means to society's ends. And, as Kant contends, this would be immoral on government's part because it effectively de-humanizes the uninsured by not respecting their freedom of choice.

Some hold that what justifies government in mandating health insurance it that it is only mandating for all what is a basic civic responsibility. But why is it your civic responsibility to lower my health insurance premiums, any more than to lower my car payment, mortgage payment or auto insurance premiums? What makes the case of health insurance unique in this regard?

The Obamatons owe the American people an answer. And they need to provide it before they destroy the finest health care system on the face of the earth in order to provide forced coverage to the less than 15 percent of the population that remains without insurance either because they so chose, or – more likely – because they are welfare slackers who simply prefer not to work or pay premiums.

Even if society does occasionally get stuck with an uninsured person's bill (predominantly those of the welfare slackers), this is slim reason for universally mandated coverage---especially if harm can be done to citizens by penalties for non-compliance. We are also causing harm to the person who has other priorities but is forced to lay them aside to pay for mandated health insurance, or be dragooned into doing so by government mandates.

So, yes, Rush, there is an analogy between health insurance and auto insurance – and, as Kant observed, government has as little right or reason to mandate the former as the latter.

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Alternatives to ObamaCare

By John Mackey, co-founder and CEO of Whole Foods Market Inc.

With a projected $1.8 trillion deficit for 2009, several trillions more in deficits projected over the next decade, and with both Medicare and Social Security entitlement spending about to ratchet up several notches over the next 15 years as Baby Boomers become eligible for both, we are rapidly running out of other people’s money. These deficits are simply not sustainable. They are either going to result in unprecedented new taxes and inflation, or they will bankrupt us.

While we clearly need health-care reform, the last thing our country needs is a massive new health-care entitlement that will create hundreds of billions of dollars of new unfunded deficits and move us much closer to a government takeover of our health-care system. Instead, we should be trying to achieve reforms by moving in the opposite direction—toward less government control and more individual empowerment. Here are eight reforms that would greatly lower the cost of health care for everyone:

* Remove the legal obstacles that slow the creation of high-deductible health insurance plans and health savings accounts (HSAs). The combination of high-deductible health insurance and HSAs is one solution that could solve many of our health-care problems. For example, Whole Foods Market pays 100% of the premiums for all our team members who work 30 hours or more per week (about 89% of all team members) for our high-deductible health-insurance plan. We also provide up to $1,800 per year in additional health-care dollars through deposits into employees’ Personal Wellness Accounts to spend as they choose on their own health and wellness.

Money not spent in one year rolls over to the next and grows over time. Our team members therefore spend their own health-care dollars until the annual deductible is covered (about $2,500) and the insurance plan kicks in. This creates incentives to spend the first $2,500 more carefully. Our plan’s costs are much lower than typical health insurance, while providing a very high degree of worker satisfaction.

* Equalize the tax laws so that that employer-provided health insurance and individually owned health insurance have the same tax benefits. Now employer health insurance benefits are fully tax deductible, but individual health insurance is not. This is unfair.

* Repeal all state laws which prevent insurance companies from competing across state lines. We should all have the legal right to purchase health insurance from any insurance company in any state and we should be able use that insurance wherever we live. Health insurance should be portable.

* Repeal government mandates regarding what insurance companies must cover. These mandates have increased the cost of health insurance by billions of dollars. What is insured and what is not insured should be determined by individual customer preferences and not through special-interest lobbying.

* Enact tort reform to end the ruinous lawsuits that force doctors to pay insurance costs of hundreds of thousands of dollars per year. These costs are passed back to us through much higher prices for health care.

* Make costs transparent so that consumers understand what health-care treatments cost. How many people know the total cost of their last doctor’s visit and how that total breaks down? What other goods or services do we buy without knowing how much they will cost us?

* Enact Medicare reform. We need to face up to the actuarial fact that Medicare is heading towards bankruptcy and enact reforms that create greater patient empowerment, choice and responsibility.

* Finally, revise tax forms to make it easier for individuals to make a voluntary, tax-deductible donation to help the millions of people who have no insurance and aren’t covered by Medicare, Medicaid or the State Children’s Health Insurance Program.

Many promoters of health-care reform believe that people have an intrinsic ethical right to health care—to equal access to doctors, medicines and hospitals. While all of us empathize with those who are sick, how can we say that all people have more of an intrinsic right to health care than they have to food or shelter?

Health care is a service that we all need, but just like food and shelter it is best provided through voluntary and mutually beneficial market exchanges. A careful reading of both the Declaration of Independence and the Constitution will not reveal any intrinsic right to health care, food or shelter. That’s because there isn’t any. This “right” has never existed in America

Even in countries like Canada and the U.K., there is no intrinsic right to health care. Rather, citizens in these countries are told by government bureaucrats what health-care treatments they are eligible to receive and when they can receive them. All countries with socialized medicine ration health care by forcing their citizens to wait in lines to receive scarce treatments.

Although Canada has a population smaller than California, 830,000 Canadians are currently waiting to be admitted to a hospital or to get treatment, according to a report last month in Investor’s Business Daily. In England, the waiting list is 1.8 million....

Health-care reform is very important. Whatever reforms are enacted it is essential that they be financially responsible, and that we have the freedom to choose doctors and the health-care services that best suit our own unique set of lifestyle choices. We are all responsible for our own lives and our own health. We should take that responsibility very seriously and use our freedom to make wise lifestyle choices that will protect our health. Doing so will enrich our lives and will help create a vibrant and sustainable American society.

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Obama's ignorance of the practice of Medicine

Why is the president convinced so many doctors and patients are making irrational decisions?

By SCOTT GOTTLIEB

On the defensive because of an increasingly skeptical public, President Barack Obama has recently spoken extemporaneously about his health plan. In doing so, he has revealed his lack of understanding about aspects of medical practice and the reasons for rising health-care costs.

One theme the president has focused on is doctors' motives. During a prime-time press conference on July 22, the president referred to a doctor who muses that she makes "a lot more money if I take this kid's tonsils out" —even if the child might not need surgery. Responding to a woman whose spry 100-year-old mother was given a needed pacemaker despite her age, the president said a few weeks earlier (at an ABC News town-hall event at the White House) that doctors should let patients know that sometimes "you're better off not having the surgery, but taking the painkiller."

Mr. Obama's clinical scenarios represent an excessive —if not erroneous— take on how doctors are influenced by financial incentives. This jaundiced view on medical decision-making may explain why programs the White House is proposing to lower health-care costs rely on the direct regulation of medical decisions. If Mr. Obama is serious about lowering costs, he'll need to reform the economic structures in medicine —especially programs like Medicare.

Medicare data shows that for the most part, major surgeries aren't the source of waste in health care. These kinds of procedures are typically guided by clear clinical criteria and are closely scrutinized by doctors and patients alike. Rather it is in routine procedures and treatments that economic incentives factor heavily into doctors' decisions.

The use of branded over cheaper generic drugs until recently fell into this category. Doctors would regularly prescribe the more expensive option. Today this is far less prevalent, since patients with private plans realized that they were being saddled with higher co-pays when they opted for the brand-name drugs over generic alternatives.

Other areas where doctors have been accused of excessive utilization include radiology scans and home medical equipment. In the absence of financial incentives to restrain excess use, relatively safe diagnostic procedures can often be justified —even if their benefits are slim.

Instead of addressing the distorted financial incentives that influence these kinds of routine tests and treatments, Mr. Obama's policies seek to directly regulate doctors and their decisions.

The Obama administration has proposed establishing an "Independent Medicare Advisory Committee" to set binding rules on Medicare reimbursement policies. Mr. Obama has also called for the creation of a new federal entity that would conduct "comparative" research on the cost-effectiveness of various treatments in order to establish federal "guidelines." The House health reform bill calls for "health information tools" that would enable Medicare to deny payment for a particular treatment right in the doctor's office.

Regulating medical decisions should not be the responsibility of a remote Washington bureaucracy. The only way to instill more reflection at the point of medical decision making is to give doctors and patients reasons to consider the cost of various options. For doctors whom Medicare pays per intervention, the problem isn't the fee-for-service model, but the way that the government program sets the fees. Fees are set according to a fixed price schedule with no tie to the physician's quality, experience level, or the outcome of the service. A more rational system would pay doctors for entire "episodes of care," rather than individual procedures. Private health systems like the Geisinger Clinic and some Blue Cross plans have adopted this model and pay doctors for taking care of an entire illness.

Medicare doesn't have the ability to track episodes of care. It has struggled to adopt even modest payment reforms such as restricted panels of providers, value-based insurance, and account-based coverage, where consumers control their own spending —all techniques used by private insurers to improve efficiency.

Medicare's size demands that it keep payment systems simple. Thus it relies on fixed prices for checklists of services tied to discrete billing codes. These uniform payment rules reward low and high quality care the same. What's troubling is that the heart of the president's plan —a government-run "public" insurance program— is modeled directly on Medicare.

Medicare compounds its shortcomings by insulating patients from costs. This causes a total lack of financial restraint at the point of care. Cost-sharing in Medicare has actually declined over time as a percent of patients' total health bill.

My colleague at the American Enterprise Institute, Tom Miller, estimates that U.S. patients have the lowest out-of-pocket costs as a percent of total national health spending of any developed country except France, Luxembourg, the Czech Republic and Ireland. They're even lower than the single-payer health system in Canada. Mr. Miller calculates that out-of-pocket spending on physician and clinical services in the U.S. was about 60% of total real per capita spending on health care in 1960. By 2002 it had fallen to 10%.

Unsurprisingly, Medicare data show that over the past two decades Medicare's costs for care have sharply outpaced spending in private plans, where co-pays and cost sharing are standard. While these estimates are confounded by factors such as the age of Medicare's population, Medicare certainly hasn't been austere.

Mr. Obama says as much as one-third of medical spending is wasted on services that provide little or no benefit. But closer scrutiny of these kinds of marginal medical decisions can't be imposed by government regulation. Cost consideration must be internalized at the point of care by patients and doctors with a stake in the price, as well as the outcome.

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