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The Edmund Burke Institute has launched a new magazine called Reflections.  The purpose of the magazine is "to launch a conservative moral and intellectual revival. We will bring together the finest minds and writers to defend the eternal principles of God, country and family. We seek to forge a reinvigorated conservative movement for the 21st century-one that champions a new nationalism, rooted in a culture of life, small government, a restoration of federalism and victory over Islamist terrorism. The time has come for a one-nation conservatism that reaches out to minorities and women, the unborn and the poor, workers and students. The movement must go beyond its traditional base or else suffer a slow, agonizing death."

Well the editors made an exception with regard to finest minds and allowed me to contribute to the inaugural edition.  Here is my article, written before the "stimulus" bill was rammed through the House, on how health care would become a bailout boondoggle.

Have a look here.

NICE Breaker?

  • 02.04.2009

The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has reversed it’s earlier decision to deny payment for (sunitinib malate) and will pay for it as a first-line treatment for patients with metastatic renal cell carcinoma mRCC (advanced kidney cancer). 

According to NICE, “Sutent provided a step-change in the first-line treatment of advanced and/or metastatic RCC and [NICE] noted that more than 20% of the public and patients that responded in consultation highlighted this impressive benefit from sunitinib.”

(More than 7,000 people are diagnosed with kidney cancer in the UK each year and approximately 3,600 people die from the disease.)

This reversal is effectively an acknowledgment that the agency hasn’t worked as intended.
 
And just what caused the the reversal?  Why evidence, of course.

A spokeswoman for NICE said the organization was reevaluating Sutent because "there was more evidence submitted during a couple of periods of the appraisal process by manufacturers, which needs to be discussed by the [appraisal] committee.”

Couldn't have been anything else, right? Well, according to a report in The Guardian,

“The move follows British Health Secretary Alan Johnson's decision this month to overhaul the way new medicines are assessed for terminally ill patients. Denying cancer patients access to drugs that are widely available abroad has become a major political issue."

Here's what NICE Chairman, Sir Michael Rawlins had to say, "We must be fair to all the patients in the National Health Service, not just the patients with macular degeneration or breast cancer or renal cancer. If we spend a lot of money on a few patients, we have less money to spend on everyone else. We are not trying to be unkind or cruel. We are trying to look after everybody."

As Robert Jones (a retired Glaxo Wellcome executive and former member of EFPIA's economic policy committee from 1994 to 2006, and its chairman from 1994 to 2001) writes:

“At the root of NICE’s operations is a Benthamite approach to health benefits. For NICE, value equates to social utility, the optimisation of which informs all of its judgments. Some of NICE's decisions may seem cruel in human terms, and ill-advised in public relations terms, but there is an arid logic to them which can usually be seen at work.”

Utilitarianism isn’t a one-dimensional worldview.  Consider Bentham’s comment that,

“It is vain to talk of the interest of the community, without understanding what is the interest of the individual.”

Is the Sutent decision a NICE breaker?

Don Berwick of the Institute for Healthcare Improvement is being mentioned to head up CMS.  He is a single payer who believes that we can cut 40 percent health care spending no prob by following the Commonwealth Fund manifesto....which reads like a 200 page endorsement of NICE

Here is Berwick claiming that the US can ratchet down cost to UK levels and be just fine.....

"..... It is manifestly possible for a Western democracy to give all the care its population needs for about 10 percent of GDP. It is possible. You can't say it's not possible because it's being done. We're at 16 percent or 17 percent. We're wasting probably 40 percent or 30 percent of the dollars we're putting into health care. That's true and I don't understand, Michael I know will come at me on this, why we just don't target that as an aim, reduce the total cost. Thirty percent waste easily in our system. I think he wants to get there by working on quality and value and that's probably right, but don't take your eye off the ball. "

"...integrated care for chronic illness and the gaps there in. The Commonwealth Fund is now our lead, I guess, scrutinizer of that problem. Seventy percent of costs go into chronic illness care. Probably half of it is pure waste. And a lot of it happens because we don’t have the integrated flows that we need for a restructured care system.
"The third really might be American exceptionalism. It’s our inability to learn from successful models outside of this country. Countries that function with better care than we have; we are 19th out of 19. That’s OECD data, that’s what Senator Baucus said and he’s right, compared to countries that are functioning at 60 or 70 cents on our health care dollar.
"We’ve got to learn from these other models and not throw them away because we assume that stuff like that doesn’t work here. It will. It’s our decision, what we choose we can choose to change."

So we should ration access to new drugs and treatments?  Is there any evidence that care -- where waiting times are longer and primary care is vastly overused -- is more "integrated?" 

 "My wife is Under Secretary for Energy in Massachusetts and she has taught me about decoupling in the energy world where utilities now in at least 20 states or so, aren’t paid for volume. They can make as much money by saving a kilowatt as by making one. We need to do that with care. You ought to be able to somehow treat an empty bed as an asset. Right now we don’t do that at all. "

An empty bed as an asset?  What does that mean?  Should we fill beds to make money? 

mcclellan for HHS?

  • 02.03.2009
Good for the administration and health care....

Daschle Packs It In

  • 02.03.2009
How fast did President Obama go from being strongly behind Daschle to telling him to head back to South Dakota?  One thing is now certain: the inevitability of health care reform Obama or Baucus style is no longer.... Is there is an opening here for patient-centered provision of coverage? 
The focus on Senator Daschle's failure to pay taxes in a timely fashion should shift to examining who controls and gets the $1.1 billion in comparative effectiveness money that goes to Agency for Healthcare Research and Quality.  That cash will be doled out  in large part on the sole discretion of Daschle  himself who wants NICE-like comparative effectiveness rulings to determine tax benefits for insurance deductibilty.  The rest is under the control of Carolyn Clancy and a handful of "stakeholders" largely beholden to to HMOs and ties to think tanks with funding from trial attorneys and foundations that support attacks on medical innovation and want a government take over of healthcare.  In addition, the institutes carrying out the work are creatures of the HMOs themselves or contractors thereof. 

No media scrutiny whatsoever and yet more than $1 billion of tax dollars to be spent in the stimulus....

Way to go.  The media is complicit in the creation of a slush fund for Daschle that pales in comparison to whatever tax filing mistake he may have made. 
"I believe for the first time in American history, health care reform will be done."

That's the incoming Secretary for Health and Human Services, Tom Daschle, speaking at a national conference on health care reform in December.

Daschle is right to be optimistic. Too many Americans lack health insurance, and there are many opportunities for reform.

Unfortunately, his reform ideas center on the government's playing a larger role in the health care market. This concept is popular among voters, as there's a widespread perception that health care systems abroad are a runaway success. The media tends to present those systems in the best light possible, highlighting their apparent benefits and ignoring their downsides. As a result, many Americans have overly positive visions of what life is like under universal health care -- and so support its creation here at home.

The truth is that government-controlled health care is not free. It comes at a great cost in the form of high taxes, long waiting lines and frequent denials of coverage.

French citizens pay about 20 percent more in income tax than Americans, according to the Organization for Economic Cooperation and Development.

The Fraser Institute reports that Canadians face an average wait of almost 18 weeks between a general practitioner's referral and actual treatment by a specialist.

In the United Kingdom, the national health care agency won't cover treatments with a yearly cost of more than $46,000. British citizens pay 11 percent to 12 percent of their weekly income to finance the country's health care system. Many popular pharmaceutical drugs aren't covered by public insurance.

It's estimated that about one- fifth of taxes collected in Canada go toward funding the country's health system.

So much for "free" health care.

Most universal health care systems also impose strict price controls on pharmaceutical drugs. But, as a new study from the Rand Corp. finds, introducing similar price regulations in the U.S. would stifle drug innovation, resulting in reduced average life expectancy.

The costs of universal health care are real and substantial. It's imperative that voters and legislators see the other side of the story before any reforms are implemented.

For the rest of the story, have a look at this op-ed from the Chicago Sun-Times.

When I was working on the issue of DTC and patient information a couple of years back (my report may be downloaded here) , I sometimes wondered why a European firm didn’t simply take out an ad to say : "We have many drugs that could help you, but we are not allowed to tell you about them."

The other day, some oncologists in Denmark did a similar thing. According to some new authority, there is no evidence that the benefit from the cancer medicine Avastin outweighs the negative impact of side-effects. This would justify the decision not to make this product the first choice when treating lung cancer.

The oncologists begged to differ, and circulated a letter to the concerned patients to inform them of their view.

According to the Swedish website Dagens Medicin, the central authority Danske Regioner will now stop this letter from being sent.

Said the politician in charge : "It would be very unethical to distribute such letters now that we have done so much to build confidence in Danish cancer treatments."

Really ? Is it more "ethical" to silence doctors who actually believe in the benefits of a certain treatment ? Probably not; but this is about saving money, sorry, rational use of drugs.



Here's the black box warning that has been attached to Darvon and it's generic version's for years:

"Darvon should not be used by people who are suicidal or who easily become addicted to medicines, alcohol, or other substances. Do not take more of Darvon than the dose your doctor prescribed. Taking excessive doses of Darvon by itself, with other medicines, or with alcohol may cause serious side effects and could be fatal. Limit the amount of alcohol you drink while you are taking Darvon . Tell your doctor if you have a history of any substance abuse, mood or mental disorders, suicidal thoughts or attempts, or if you take any medicines that cause drowsiness such as tranquilizers, sleep medicines, muscle relaxers, or antidepressants."

And here is an Time Magazine article about Darvon and the efforts of Sid Wolfe, now an offical pain the you know what as a member of the Risk Benefit advisory committee for the FDA, to ban the drug:

"... Wolfe asked for an immediate ban on the sale of the widely prescribed pain reliever propoxyphene, best known as Darvon. He claimed not only that Darvon is an ineffective painkiller, but also that in excessive doses it produces a euphoric high, which he says, "makes it attractive as a drug of abuse. This is tantamount to legalized dope." Further, said Wolfe, Darvon-related deaths in the U.S. have been increasing, rising in major cities to about 600 last year and making the compound "the deadliest prescription drug in the United States." Eli Lilly and Co., of Indianapolis, the principal manufacturer, promptly branded Wolfe's charges "irresponsible and clearly not supported by the facts."

Darvon-related deaths have often involved intentional misuse, either by overdosing or mixing with alcohol and other drugs. Lilly notes that the average person would have to take 30 large-size Darvon capsules at one time (the usual dose is one every four hours) to cause death, 15 if he were intoxicated. Further, the drug is a controlled substance—a prescription is good for only five refills within six months. (If HEW will not ban Darvon, Wolfe wants the drug reclassified so that prescriptions cannot be refilled.)

Lilly also says that Wolfe's claim about Darvon's effectiveness is misleading because it is largely based on studies of single, rather than multiple, doses of the drug. Doctors prefer Darvon for some patients because, unlike aspirin, it does not cause gastrointestinal bleeding or lower the body temperature. Concludes Lilly's Dr. Robert Furman: "Used as directed, Darvon is really very safe. The fact that some people are intent on abusing it shouldn't be used to indict it."

Read More

That article was written 40 years ago. Wolfe was petitioning the FDA then.

I can't say I totally disagree with Wolfe's motives. Darvon and Darvocet were and are the drug of choice for people who seek to commit "peaceful suicide' and is pushed as such by pro-suicide groups and chat rooms. The problem is, banning the drug will remove another effect medicine for menstrual cramps that does not cause internal bleeding and if the UK is any guide those seeking to commit suicide or use painkillers recreationally will use medicines that are stronger or have worse side effects than liver toxicity.

Wolfe's persistence is an example of ideology overriding science and the doctor-patient relationship. The Sid Wolfe fan club (Alicia Mundy, President) might delight in his longstanding effort to drive drugs he detests off the market but for many people, including me and family members, his personal choices would come at the expense of our very lives.

Sooner is Better

  • 02.02.2009
"The president hopes in the next few days to announce a pick for commissioner at FDA," White House spokesman Robert Gibbs told a press briefing.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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