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November 30, 2007

Open Source AEs

by Peter Pitts

Mark McClellan (“the hardest working man in American health care") told a gaggle of biotech executives at Lazard Capital Markets' 4th annual health care conference that a new bill passed by Congress will create a vast new database of drug patients by 2012.

McClellan said major health care organizations such as eHealth Initiative, Partners Healthcare and Kaiser Permanente will coordinate with insurers like Wellpoint, Inc.and Unitedhealth Group to gather and collate the data from patients. This initiative is part of the FDA Amendment Act of 2007.

"Most of the evidence on your products will be coming from sources other than you," said McClellan, who sees the information as being more complete and more objective.

If all members of the American health care system can work together and following the same rules (in how they define adverse events and how they use the data) “you've got tens of millions (of people) in the database," said McClellan.

Posted by peterpitts at 10:55 AM
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November 28, 2007

The Greening of the American Health Care Paradigm

by Peter Pitts

Last week the Center for Medicine in the Pubic Interest (CMPI) and the Duke University Center for Research on Prospective Health Care hosted the second meeting of the Patient Centric Health Leadership Forum.

Yes, that’s patient-centric – the counterpoint to cost-based – health care.

The day was kicked off by Ralph Snyderman, Chancellor Emeritus, Duke University and Chair of the Patient Centric Leadership Forum. Dr. Snyderman made the day’s opening presentation forever memorable by making a crucial point...

... since we are all embracing the concept of a “sustainable planet,” we should understand that such a notion must begin with the essential consideration of a “sustainable individual.”

And that means a focus on “Prospective Health” with five key components:

* Health risk assessment tools
* Therapeutic evaluation tools
* Aligned health care providers
* Aligned reimbursement systems
* Motivated consumers

Difficult to be sure. But as the great health care philosopher Kermit the Frog opined, “It isn’t easy being green.”

Posted by peterpitts at 08:58 AM
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November 27, 2007

You mean it isn’t “free?”

by Peter Pitts

What’s the difference between “universal” health care and “government” health care?

The sad answer is that the first is a good political sound bite and the latter is not. The truth is that they’re the same thing -- and neither is “free.”

There is no such thing as “health care from heaven.” Just ask the citizens of any nation in the EU or Canada. Better yet, ask Illinois’ Governor Rod Blagojevich whose plan for “free” and “universal” coverage in the Prairie State (designed to be funded via a very un-free $7.6 billion gross receipts tax on Illinois businesses) went down in flames in the state legislature 107-0 ... after the Governor came out against his own idea.

As the Wall Street Journal opined, “'Universal' government health care has once again returned as a political cause, with many Democrats believing it's the key to White House victory in 2008. They might want to study last week's news from Illinois, where Democratic Governor Rod Blagojevich's tax increase to finance health care became the political rout of the year."

Some candidates for the presidency are beginning to get the picture – others not so much. Here’s an article from the New York Times that points out the problems of sound-bite health care plans:

http://www.nytimes.com/2007/11/25/us/politics/25mass.html?_health&oref=slogin

There’s no such thing as a free lunch – or “free” health care.

Posted by peterpitts at 09:04 AM
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November 26, 2007

Apples & Oranges

by Peter Pitts

The nation’s largest healthcare payers are embracing the use of what is known as “comparative effectiveness,” a fancy term for essentially evaluating different therapies for a particular condition based on their costs and efficacy. The trend is a politically popular way to help reign in the cost for drugs, devices, and procedures. And the move reflects a broader focus on cost, rather than care that is taking place at all levels of the American healthcare system.

But it’s important to move beyond criticizing comparative effectiveness in its current form, and instead towards creating a policy roadmap for integrating technologies and science that is more patient-centric into comparative effectiveness thinking.

Much the like the U.S. Food and Drug Administration created the Critical Path Initiative to apply 21st-century science to accelerate the development of personalized medicine, another national goal should be to create a Critical Path Initiative to apply new approaches to data analysis and clinical insights to promote patient-centric healthcare.

Why? Because comparative effectiveness should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, or prevent disease. First steps have been taken. For example, the Department of Health and Human Services has invested in electronic patient records and genomics. Encouraging the Centers for Medicare & Medicaid Services to adopt the use of data that takes into account patient needs would complement such efforts.

Here's the rest of the story as explained in a new article in The Journal of Life Sciences:

http://www.tjols.com/article-421.html

Posted by peterpitts at 08:48 AM
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November 23, 2007

A NICE Backdoor

by Peter Pitts

According to CMS Chief Medical Officer Barry Straube, the possibility of simultaneous FDA and CMS evaluations of new devices is again under consideration by agency officials. Straube, who also directs the CMS Office of Clinical Standards and Quality, said his agency is working with FDA on a proposal for parallel review, which could be made public in the "relatively near future."

In 2005 FDA officials suggested that a Federal Register notice would soon outline a way for companies to request parallel reviews as a way to streamline the normally sequential marketing-approval and Medicare-coverage processes.

"We came very close to putting together a pilot project two years ago, but it kind of got put to the back burner for reasons I'm not even sure of," Straube said.

Involving CMS in premarket studies "is highly problematic," commented AEI's Scott Gottlieb, in part because CMS lacks expertise in clinical trial design. He also points out that Industry is worried that proprietary data, which FDA must by law protect, will not remain confidential if it is shared early on with CMS, which is subject to different disclosure mandates.

I may have been born at night – but not last night, Dr.Straube. This is a back door to cost effectiveness in the FDA review process, or at the least, that is what it will become if we allow the cost-effectiveness gang to have their way.

Posted by peterpitts at 10:26 AM
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November 07, 2007

Debunking Some Health Care "Urban Myths"

by Peter Pitts

Like they say, everything you read in the newspaper is true except for those things you know about personally. This isn't always how urban myths begin -- but is certainly one of the most potent ways they are perpetuated.

Three of the most common "urban myths" of American health care (courtesy of folks like Michael Moore, Paul Krugman, et. al.) are that (1) the infant mortality rate in the US "proves" the total inadequacy of our system, (2) there are 47 million uninsured Americans -- proving the inequity of our system, and (3) We spend "too much" on health care -- proving the wastefulness of our system.

As the Ol Perfessor used to say, "Let's look at the numbers."

1. Infant Mortality

According to N. Gergory Mankiw, Professor of Economics at Harvard University, "The United States has lower life expectancy and higher infant mortality than Canada, which has national health insurance." This fact, according to Mankiw, is often taken as evidence for the inadequacy of the U.S. health system. But a recent study by June and Dave O'Neill, economists at Baruch College, from whom these numbers come, shows that the difference in health outcomes has more to do with broader social forces.

According to Manikow, "Americans are more likely than Canadians to die by accident or by homicide. For men in their 20s, mortality rates are more than 50 percent higher in the United States than in Canada, but the O'Neills show that accidents and homicides account for most of that gap. Maybe these differences have lessons for traffic laws and gun control, but they teach nothing about the U.S. system of health care.

Americans are also more likely to be obese, leading to heart disease and other medical problems. Among Americans, 31 percent of men and 33 percent of women have a body mass index of at least 30, the dividing line between overweight and obese, versus 17 percent of men and 19 percent of women in Canada. Research by the Harvard economists David Cutler, Ed Glaeser and Jesse Shapiro concludes that the growing obesity problem in the United States is largely attributable to its ability to supply high-calorie foods inexpensively.

Infant mortality rates also reflect broader social trends, including the prevalence of infants with low birth weight, which is correlated with teenage motherhood. Whatever its merits, a Canadian-style system of national health insurance is unlikely to change the sexual mores of American youths"

2- 47 Million Uninsured

This number from the Census Bureau is often cited as evidence that the health system is failing for many families. Yet, as Mankiw observes, "by masking tremendous heterogeneity in personal circumstances, the figure exaggerates the magnitude of the problem."

The 47 million includes about 10 million residents who are not U.S. citizens. Many are illegal immigrants. Even with national health insurance, they would probably not be covered.

The "Big Number" also includes millions of the poor who are eligible for Medicaid but have not yet applied. Per Mankiw, "they are uninsured in name only."

And about a quarter of the uninsured have been offered employer-provided insurance but declined coverage.

3- We spend "too much" on health care

In 1950, Americans spent about 5 percent of their income on health care. Today the share is about 16 percent. Mankiw believes that "many pundits take the increasing cost as evidence that the system is too expensive.But increasing expenditures could just as well be a symptom of success."

And he hits a homerun with a clear. concise, and uncomplicated explanation. "The reason Americans spend more than their grandparents did is not waste, fraud and abuse, but advances in medical technology and growth in incomes. Medical science has consistently found new ways to extend and improve lives. Wonderful as they are, they do not come cheap."

Consider the question posed by economists Charles Jones of the University of California and Robert Hall of Stanford: "As we grow older and richer, which is more valuable: a third car, yet another television, more clothing - or an extra year of life?"

Perhaps this should be added as a question to the next spate of Presidential debates?

Posted by peterpitts at 10:29 AM
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