FDA Oversight of Medical Devices

I have a tight schedule today, so I am using my blog to footnote an interesting resource.  Srihari's blog on FDA review of medical devices is good, and his post yesterday was excellent. In it, he summarizes a presentation by Elias Mallis, the Chief of Cardiac Electrophysiology and Monitoring Branch (CEMB) at the Division of Cardiovascular Devices in the FDA.


Take a look at it!

Do All Doctors Hate Practicing Medicine?

A New York Times blog post and its accompanying article today make some interesting points about the attitudes of doctors on practicing medicine in today's health system, including their feelings about the coming changes in health reform. But the blog post and article miss perhaps the most interesting point of all: the kind of medicine a doctor practices may have the strongest influence of all on their attitudes about the practice of medicine.

In the US, a whopping 75% of physicians are specialists while only 25% practice primary care. Why this imbalance? I'm not sure how many people know this: in the US, a primary care doc makes about $140K to start and a radiologist makes about $340K to start. Medical school graduates in the US flock to higher paying specialties and there is no doubt that projected income is a major factor in their decisions. In 2009, just 10% of Harvard Medical School graduating class of 165 went into primary care. By contrast, Tufts graduated 17% and UMass graduated 39% into primary care. These are scary numbers, especially those at institutions that are supposed to be on the leading edge of medical education.

Which kind of doctor is happier with the current system and the prospects of health reform? This question has to be explored, and the answers may not be what you'd expect. At least on the changes coming in health reform, my hunch is that many primary care doctors are more likely than their specialist counterparts to be supportive. Primary care doctors should especially like increases in their authority to control global payment under accountable care organizations and medical home intiatives. Health reform, if done right, could reduce the gap between primary care pay and specialist pay.

Changes like these will probably make a radiologist seethe, but they could cause a primary care doctor to celebrate. Primary care doctors may have legitimate gripes today, but they could soon see changes they will like.

Epistemic Closure, By any Other Name...

There has been a lot of talk recently about "epistemic closure," a term coined weeks ago by the conservative thinker Julian Sanchez of the libertarian Cato Institute, to describe the closure of conservative minds to facts and arguments that do not already reflect their own views. Epistemic closure is also called "cocooning," a term that evokes the image of hiding from information outside one's own bubble. The term is borrowed from the philosophical discipline of epistemology and it means something entirely different in that context. The assertion, as made first by Sanchez and now by many others, is that contemporary conservatives are more likely than contemporary liberals to suffer from epistemic closure of the cocooning kind.

I need to weigh in on this, because:

1. I believe the assertion is true - today's conservatives are more likely than today's liberals to reject facts and arguments that do not already conform to their views
2. It has affected the health reform debate in negative ways
3. It is corrosive to democracy because there can be no debate when one "side" refuses to debate at all
4. A popular movement is needed to oppose this phenomenon, but I don't think the term epistemic closure will help popularize the movement.

I believe the description of this phenomenon is valid, but there is a difference between rejecting arguments and rejecting facts. Rejecting an argument is - sometimes - the natural outcome of discussion and debate. Some arguments can and should be rejected. However, rejecting a fact is difficult and perhaps impossible to justify. Republicans and the right wing should be encouraged to engage in debate if they desire and to oppose liberal and left wing arguments, and vice-versa. But no one should be encouraged to oppose a fact or to be hostile to evidence.

Hostility to facts and evidence is a phenomenon that has been growing on the right in the US for several decades. The current wave may have started with Barry Goldwater's declaration that "extremism in defense of liberty is no vice." Wherever it started, it seems clear to me that all policy options in the GOP have been reduced to a war of principle between the liberty gained by lower taxes and the liberty lost by social compacts. The tea party and birther revanchists ("taking our country back") are just two variants of a right wing movement that is hostile to facts and evidence. From global warming to economic policy, to Obama's birthplace and taxes, these movements have made facts and evidence into enemies.

This phenomenon is corrosive to democracy, and it is a primary reason I worry about the future of the United States. It is an act of stupidity to oppose a fact or to be hostile to a piece of evidence. I worry that there are no true conservatives in power these days. From my vantage point, the House and Senate GOP, birthers and tea party activists are all of a common cloth: they reduce every policy debate to a fight of principles and ideas rather than a debate about the facts and the evidence. These people are radicals, driven by ideologies and not by facts. They are market fundamentalists and religious fundamentalists, whose default stance is total war on their opposition, even if the opposition appears in the form of overwhelming evidence. Need examples? Evolution. Global Warming. The inefficiency of free markets in healthcare.

This stance is not good for a country of 300 Million people that is trying to work out difficult policy solutions in a global economy and a fast changing political landscape. Take the health reform debate. The final Act, as passed, is based primarily on conservative ideas originating with the Romney Administration in Massachusetts, but it did not garner a single GOP vote. It got no GOP support despite 13 months of debate and 3 months in which the Gang of Six (3 Republicans and 3 Democrats) worked in conference to draft the legislation in the first place. I believe the GOP never intended to come to the table on health care because it clashed with their ideology of small government. The GOP could not support an increased Federal role in healthcare, period. Evidence of market failure in private healthcare was irrelevant. Evidence of government success and patient satisfaction with Medicare and the VA system was irrelevant.

This phenomenon deserves universal criticism, from both the right and the left. What is needed is a popular message that is firmly critical of hostility to facts and evidence. Although it is right on, the term "epistemic closure" presents a barrier to popularizing this criticism. Few people are willing to use the word episte-anything at the water cooler.

This needs to be said as clearly as possible: Hostility to facts and evidence should be the new definition of dumb, and thoughtful people need to say so.

A Robust Comparative Effectiveness Research Enterprise

I post this link to the Health Affairs blog today, in part to keep it handy... for myself.  It is a must-read for health policy, health services, clinical and biomedical researchers.

http://bit.ly/b1ZvcA

Kudos to Darren Zinner, a former classmate, for his work on this!

On Comparative Effectiveness Research, Why Do So Many Bloggers Get the Facts Wrong?

Here is an example of poor quality blogging on the topic of comparative effectiveness research in medicine. Dozens and perhaps hundreds of blogs have addressed this topic in the past several months, and many of them keep repeating the same simple errors.

The blog I point you to at the top of this post, for instance, misses key facts about CER, including the definition of CER. According to the Congressional Budget Office (scroll to page 3), CER is "a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients." Other definitions taken from the  recently passed legislation (see page 1620, "PURPOSE"), the Institute of Medicine (scroll to bottom of page 1) and the now terminated Federal Coordinating Council on Comparative Effectiveness Research all point to this same idea - that CER is designed improve information about which treatments work best for which patients and under what circumstances.

Comparative effectivenes research is therefore meant to replace current practice in which summary results from clinical trials are applied to every patient, with a better practice in which patient-specific evidence from clinical research and real-world practice settings is applied to patients on a case-by-case basis.

It is clearly spelled out in every Federal document that describes the role of CER: this research is designed to make comparisons between treatments and apply the results to individuals, not to whole populations.

A second major gaffe in this blog suggests that the information will be used by some invisible hand (read: government) that stops the use of certain medical interventions. This blogger writes: "Comparative effectiveness research is the process of comparing the costs and the results of various treatments to decide whether the more expensive treatments actually yield better results. And of course if the answer is no, the more expensive treatments stop being used (for the most part)."

I'm not sure what "(for the most part)" is supposed to mean. This claim is false. It can be contrasted with the newly passed law, which actually states:

"The [CER] Institute shall ensure that the research findings ...  not be construed as mandates for practice guidelines, coverage recommendations, payment, or policy recommendations" (pages 1634-35)

and further on:

"COVERAGE.—Nothing in this section shall be construed to permit the Institute to mandate coverage, reimbursement, or other policies for any public or private payer" (pages 1647-48)

and still further on:

"The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1181 in determining coverage, reimbursement, or incentive programs under title XVIII in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.” (pages 1652-53)‏

So, why do so many bloggers get the facts wrong on CER?  I'm pretty sure they are taking shortcuts. I'm sure it is easier to work from political talking points than to obtain verifiable source material and report on it. In the case of comparative effectiveness research, the source material is available and verifiable, but it is buried under a mountain of low quality blogging.

The President's Speech

I snatched this from Nick Kristoff's twitter feed earlier today.

Harbinger Geese

My brother, David Concannon, went to the extra effort to clip, scan, save and send an Op-Ed by James Carroll from the Boston Globe this morning. I thought to myself, "If he went to the trouble of digitizing print media in the era of hyperlinks and e-mail, it must be really good."

It is good.

Thanks Dave!  Here's an image of the real life print version. 

Coming Between You and Your Doctor

Another well written piece in today's blogosphere:  Coming Between You and Your Doctor

Why Comparative Effectiveness Research is Needed

Should health insurers be held accountable for skyrocketing premiums?

Congress and the President are beating up on health insurers for raising premiums at rates that are literally killing people. The rate increases are so high that many people who desperately need health care will no longer be able to afford their premiums. Anthem Blue Cross, for instance, raised rates for non group coverage as much as 39% this year: www.bit.ly/9uNKw6.

While increases of 39% are no doubt extreme, health insurers are not the sole villains in this story. Behind these increases are sharp increases in the sale and use of unnecessary high tech medical care. Medical device and pharmaceutical manufacturers, hospitals and specialist physicians have been overselling questionable medical technology to US consumers for decades. They have been dipping into our wallets without our permission and it is time we figured out how to make them stop. In today's Washington Post health blog (www.bit.ly/98BfPK), Ezra Klein points out correctly that insurers tried to say no to some of these practices in the 1990s, and they got killed in the courts over it.

Health insurance premiums are by definition equal to health spending plus health insurance overhead. While overhead might be too high, the real reason that premiums are going up is that spending is going up.

Medical care seems to get less value from technology than other industries do. One reason for this is that physicians and hospitals regularly oversell unnecessary high tech procedures at an astounding rate. For example, a recent study in the Journal of the American College of Radiology www.bit.ly/a6zmev showed that 1/4 of all radiology referrals in a large medical system were unnecessary. In the US healthcare market, there are no players around to stop referrals of this kind from being carried out. All of the incentives for hospitals, specialists, medical device manufacturers, pharmaceutical companies - and yes, health insurers - are aligned keep healthcare consumers on an ever-rolling treadmill toward higher spending.

In the US, we have few solutions to this growing problem. This problem is going to continue unless we find the right way to say no to unnecessary medical care. We must find a way to stop the sellers of unnecessary medical technology from killing our wallets and our budgets. Until we do, health insurance premiums will continue to grow at rates that are literally killing people.

Map of Every Fast Food Burger in the US

This interesting map of US fast food burger joints was put together by the folks over at http://www.weathersealed.com/.  Great work!

Fast food burgers may be delicious once in a while. But what if you lived in a neighborhood that had no other inexpensive food sources?  I'd like to see map of farmer's markets and grocery store chains laid on top of this, to see where fast food restaurants dominate low cost fresh food stores.

http://www.weathersealed.com/2010/02/23/a-disturbance-in-the-force/

The Power of Better Information

In a provocatively written piece "Technology and the power to say no is real health reform" http://bit.ly/9JOZ7v, Dana Blankenhorn writes that real health reform involves saying no to the sellers of useless medical care and no to patients who refuse to make behavioral changes that would improve their health. By saying no, he means that we must stop paying for health care that doesn't work and for health care for people who don't deserve it.  I agree with his first claim and disagree with his second.

What's great about the article is the very strong case he makes for curbing the growth of healthcare costs by attacking it at the source. The growth in health care costs does not originate with the usual suspects - poor prevention, big government or with overpriced health insurance. Our problem originates with the sellers of health care - especially specialist physicians, high tech hospitals, medical device manufacturers and pharmaceutical companies. The sellers of high cost health care have been dipping into our wallets without our permission for many decades, and it is time we figured out how to make them stop.

It's the sellers of high tech health care who are causing the big hikes in health insurance premiums. It's not that we don't need some of the technologies they sell. It's that we have very little information about what we need and what we don't, and they aren't telling. They're too busy selling. 

So we need more information - comparative information - that tells us which interventions work well and which interventions are just dressing on the cake.  The Federal effort to fund better comparative effectiveness research is exactly what is needed. Once we have that information, we need to use it. We need to find the power to say no to some of these useless technologies and interventions. We need to aquire the the power to say no to the sellers of useless health care. We need to eliminate insurance reimbursements for health care that doesn't work. That's what we'll need if we want to see an end to 39% hikes in health premiums http://bit.ly/9uNKw6.

A recent article in the Journal of the American College of Radiology shows that in one large health care system in Washington State, approximately 1/4 or 26% of all referrals for diagnostic imaging services were not necessary. See a story on this study here:  http://bit.ly/a6zmev.  Many of these diagnostic procedures - x-rays, MRIs and CT scans - are very expensive, and we're paying for these procedures in our health insurance premiums. Why are we doing that and why don't we stop? Someone's got to start saying no. Dana's right about that.

That said, I don't agree with Dana that we must also learn how to deny care to overeaters, smokers and drinkers. The worst of our national health behaviors are undoubtedly killing our bodies and our wallets. However, the most effective strategies for defeating these behaviors and their outcomes - obesity among the worst of them - are not known.

We do know that obesity runs in geographic clusters.  In some regions of the country, people are overweight because there is no fresh food to be found, for miles. In these "food deserts," residents dine on fast and convenience foods. Obesity rates have skyrocketed in these areas over the last several decades. Effective strategies are needed to eliminate the deserts, not to penalize the people. To date, however, very little research has been conducted on what can be done and what might work to reduce desert-induced obesity.

Obesity also runs in social networks, and this finding has only been available since the publication of Nichoolas Christakis' groundbreaking article on that subject in the New England Journal of Medicine three years ago:  http://bit.ly/bHUmBL.  More information is needed to understand how social networks can be used to improve diet and exercise.

Interrupting the geographic and social determinants of obesity may be better than penalizing the elderly person who acquires diabetes after a lifetime of cheeseburgers.

But we need better information about what works and what doesn't. That's power.

The CEA Registry Blog: ‘Best practices’ to trim medical costs

The CEA Registry Blog: ‘Best practices’ to trim medical costs

Americans Still Want Health Reform

From a Kaiser Family Foundation poll, released today at: http://www.kff.org/kaiserpolls/8051.cfm

Question: For each element of health care reform I name, please tell me how important it is that this be passed into law. First, how important is (item)? Is that extremely important, very important, somewhat important, not too important, or should it not be done at all?

1. Reforming the way health insurance works. Proportion saying extremely or very important: 76%
2. Providing tax credits to small businesses. Proportion saying extremely or very important: 72%
3. Creating a health insurance exchange or marketplace. Proportion saying extremely or very important: 71%
4. Helping close the Medicare "donut hole". Proportion saying extremely or very important: 71%
5. Expanding high-risk insurance pools. Proportion saying extremely or very important: 70%

And here's an interesting chart:

And another:
 

Nurse Practitioners Push for an Expanded Role in Primary Care

Check out this interesting article about the push by nurses for an expanded role in primary care: http://www.bit.ly/dg7TSL. And check out this review of studies that compares advanced nursing care with physician-directed primary care: http://www.bit.ly/choFHP.

The nutshell? Advanced nursing care is often as good or better than care from a physician. And it costs less.

Although lower cost care is often equally as good or even better for the patient, there are few incentives in place to choose lower cost and lower intensity alternatives. People who are very sick may prefer to modify or even limit the intensity of the health care they receive. But everything in our system - and nearly everyone - points patients toward higher intensity.

This isn't exactly any one's fault. The whole system has us on a treadmill toward higher spending and higher-intensity care. Many insurers and health providers find themselves struggling to keep revenues high, which means the default choice is a physician over a nurse practitioner, a hospital over a community health center and a hi-tech over a low-tech intervention.

Just a little food for thought.