Special Halloween edition

A few scary thoughts for the season:

The fierce and formidable Ben Goldacre of the Guardian has a great post at Bad Science this week about the misuse of statistics in a murder trial. I need to be sure to keep this one for my files; it's a nice illustration of Bayes' Theorem.

I'm posting this creepy AP wire story, about a teenage girl who loses her breast to flesh-eating bacteria after a piercing, because its tabloid-like sensationalism speaks for itself.

Scary, but predictable: the new Pew survey showing that only 25% of people who get health information from the Internet usually or always check the sources. Yup, that's why we're here, folks.

The original article in the journal Engineering Economist apparently is not out yet, but the Washington Post presented one of those estimates that sounds like it was thought up by a bunch of engineers chowing down on leftover Halloween candy for lunch: the additional (on average) 24 lbs in the weight of a human between 1960 leads to the consumption of an extra billion gallons of gas per year. A very silly analysis all around; as the HealthBehaviorBlog put it,

We are not spending more on gasoline because we are fat, we are fat because we are spending more to drive places we used to walk.

Finally, Doctor Hébert's Medical Gumbo hosts today's medical blogging grand rounds - in a spoof of Poe's The Raven, no less! I'm impressed...
obesity
statistics
Internet
flesh-eating bacteria
Bayes' theorem

Alternative medicine in question

Here's a really good discussion at Respectful Insolence about research on alternative medicine. I'm on agnostic on what part of NIH should fund this research, but as far as I'm concerned, once studies on a treatment or intervention rises to the level of evidence required for conventional therapies, it's no longer "alternative."

What is the practical difference between alternative and conventional therapies, anyway? I think the main distinction is in how they are treated by our irrational, two-tiered regulatory system, in which once something falls into the category of dietary supplements it's no longer subject to regulation at all, absent herculean efforts to demonstrate their dangers, as we saw with ephedra.

More importantly, how do we get consumers to understand the issue? Many consumers have evolved a similar two-tier response to things we put in our bodies: they assume that if something's natural, or simply a dietary supplement, it must be inherently safe, whereas if it's a prescription drug, some pharmaceutical company is trying to profit, so the standards of proving safety are higher. If they can appreciate that (and I could be overestimating that understanding), why is it so hard to see the profit motives in the supplement and alternative medicine industries? I would love to see data on marketing strategies for alternative medicine, if anyone knows about it. I imagine they involve a certain amount of brainwashing; specifically, they'd like us to think that Western scientific criteria simply don't apply to homeopathy, acupuncture, etc., and if alternative therapies become subject to regulation, big government is trying to take away our access.

I'd love to hear from readers about this.

alternative medicine
complementary medicine
dietary supplements

Lung cancer screening trial - how the news reports stack up

Today's New England Journal of Medicine presents the results of a study on lung cancer screening. This study purports to test the value of spiral computerized tomography (spiral CT) against lung cancer in smokers and former smokers, and reports a 92% 10-year survival rate, compared to 70% 5-year survival. Sounds pretty good, right? Well, not exactly. First of all, this study has no control groups - everyone in the study underwent screening, so the 70% number is a commonly accepted figure based on other populations. That's a problem because their diagnostic patterns differ.

Also, survival sounds intuitively like the flip side of mortality, which is the population-appropriate measure of the number or proportion of people who die from a disease, but it is not. According to a too-often-overlooked paper by HG Welch and colleagues, survival is not even a predictor of mortality. Instead, it is likely to reflect lead-time bias inherent in many screening tests - screening picks up smaller tumors early in their development, without necessarily changing the actual date of death. It's also likely that some screen-detected tumors would never go on to cause disease, and that has to be acknowledged as a risk of screening, because a false positive finding that leads to a lung biopsy can be dangerous.

I knew this study would get a lot of coverage; here's a look at a non-random, convenience sample of articles from big newspapers and wire services, and I'm not giving reporters' names because I know that editorial constraints often result in the loss of crucial details. So does mainstream coverage acknowledge the lack of control group and the 5-year survival problem?

A very good job of explaining the controversy from the NY Times:

...everyone in Dr. Henschke’s study had CT scans. And so, researchers say, with no comparison group of people who did not have scans, they are left with a pressing question: Does screening, in the end, save lives or cost lives?

“Intuitively, it makes sense —if you have a cancer, take it out,” says Dr. Stephen Swensen, a professor of radiology at the Mayo Clinic who conducted a study that was similar to Dr Henschke’s but smaller. “It makes sense that if you find a cancer earlier you will save lives,” he added. But Dr. Swensen said, “The science hasn’t backed that up yet.”

Cancer specialists have long known that all cancers - and lung cancers are no exception - include ones that stop growing and never kill or that grow so slowly that they never cause problems if they are simply left alone. So, some of them ask, how many of the people said to be cured were never in danger? And how often will people have operations that can involve removing part of a lung, and that can themselves kill a patient, when their cancer was not lethal? The problem, as with other cancer scans, is that science today cannot always tell the difference between cancers that will stop and those that will go on to kill.

The Washington Post also covered the lead-time bias and lack of control group issues well:

"We have shown that when you diagnose it early that you can cure it," said Claudia I. Henschke of Weill Medical College of Cornell University, who headed the study. "We think this provides compelling evidence that you can save lives."

Some who disagree say the study had no controls -- no group randomly assigned to have no screening or to have some other kind of screening. Without a comparison group, it is impossible to say whether the outcomes of the smokers who received CAT scans was better.

It is not surprising that people whose lung cancers are found by a CAT scan survive longer than people whose tumors are found the usual way, after they cause pain or breathing problems. Screened patients receive diagnoses earlier and therefore will have the diagnosis for a longer time than someone whose tumor is found later, even if the two people die at the same time.

from Reuters...:

But other experts immediately questioned the results and said the report was not the last word.

"What the data don't show us is that there been an actual decline in lung-cancer mortality. This study can't show us that because it is not a random comparison," said Dr. David Johnson, of Vanderbilt University in Tennessee, a former president of the American Society of Clinical Oncology.

It is possible the screening simply turned up more slow-growing tumors that would have caused little trouble for years, he said.

...and the Associated Press:

Henschke [the study's lead author] said the general population can be the comparison group, because lung cancer is so common and its survival odds are so well known. But many scientists disagreed, and said her study falls short for this reason.

"It raises great hope for CT screening," but it doesn't prove a benefit, said Dr. Denise Aberle of the University of California, Los Angeles, who is helping conduct a government-funded study that should give more definitive answers. It is screening 53,000 current and former smokers with CT scans or regular chest X-rays to see whether either can cut lung cancer deaths. The Mayo Clinic also is leading a screening study, and others are under way in Europe.

As an aside, I chuckled at the defensive wiggle-language in the AP report from the American Cancer Society's Bob Smith (ACS funded the study):

Even though the study lacked a comparison group, he said, "it's highly unlikely that this completely invalidates the observation of a favorable benefit from early diagnosis."

The Wall Street Journal acknowledged the controversy, but it was framed only by a quote from a lung cancer advocate worried that smokers were perceived to be to blame for their disease:

"It's hard to demand the same level of compassion and support as other cancers," Ms. Fenton said. "Mammographies, colonoscopies - you don't see the same doubts about these tests as you do for CT scans of the lungs."

Lack of compassion, or lack of science?

lung cancer
screening
news

Making investments in improving patient care

A Honolulu Star Bulletin article yesterday described an investment of $50 million by the Hawaii Medical Services Association in improving patient care, including $20 million towards helping its 1000 physicians implement electronic medical records (EMRs) (up to half the cost of a system per physician). It's great to see medical communities coming together this way to help small practices overcome the financial barriers. EMRs help not only in emergencies, but (ultimately, if systems become interoperable as we hope) as patients move throughout the health care system, accumulating tests and prescriptions, providing a way for providers to get an overview of the patient, and not just whatever the patient happens to be able to remember of his or her other care. It's also a great way for practices to monitor their quality of care.

health care quality
electronic medical records
Hawaii

New issue of Health Wonk Review

Another blog carnival for everyone's enjoyment; Health Wonk Review, hosted this issue by Ezra Klein, celebrates the work of health policy thinkers and writers from across the political spectrum. I am flattered to be included amongst their august ranks.

Tunnel vision and patient safety

An unsigned article from yesterday's AP wire, about a woman who was temporarily paralyzed from too rapid administration of a painkiller during childbirth, made me sad. Sad for the unfortunate patient, yes, but sadder still for the country's collective (mis)understanding of how such incidents really happen and, thus, what it takes to prevent them.

The article's lede describes a prior incident of medication error at the same hospital, in which three infants died, and then describes the current incident: Apparently the pump that delivers an epidural medication was misprogrammed, and the patient received 10 times the amount she should have over one hour (she recovered, and her baby was fine).

The article states that the hospital referred to the incident as a "doctor's mistake" - and the hospital's statement, not the putative mistake, to my mind, should have been the story. Clearly they were trying to shift the blame, but what does assigning blame do for you (the hospital that is) when what you really should be doing is getting busy figuring how this and the previous, more serious, incident happened in the first place? That means examining assiduously all of the hospital processes that take place in order for medication to get inside a patient: how medication orders are filled, the installation of the pump, instructions for operating it, how health care workers are trained to use the pump, procedures for double-checking dosages and drug names, etc., etc. It also means that you have to have data on adverse events and close calls, collected in a way that promotes understanding and facilitates prevention, and - this is the scary part for hospitals - in a non-punitive fashion. Of course, there are truly negligent practitioners out there, but the current system targets those who happen to be at the sharp end of the needle, as it were, when an error occurs.

This news story relates an anecdote or two, but medical errors are a real public health problem - such incidents lead to about 98,000 deaths per year. That's another opportunity missed by the AP writer - the opportunity to put this hospital's experience in context.

There's still time for reporters to go back to the hospital spokespeople and ask them what they're doing in terms of larger-scale changes. Are they working with organizations such as the Institute for Healthcare Improvement to reduce deaths from pneumonia and hospital-acquired infections? Are they training their executives to appreciate the business case for quality and systems' approaches to patient safety? Are they raising funds for electronic health records systems? Those are important stories, too, stories I hope consumers will come to ask for. They may not seem as gripping on the surface as stories about young moms paralyzed at the hand of negligent doctors, but in the end, they're about saving lives - many of them.

Some resources on patient safety (in addition to IHI, cited above):

AHRQ Patient Safety Network
The Institute of Medicine's landmark "To Err is Human" report
National Patient Safety Foundation
Joint Commission International Center for Patient Safety
The Leapfrog Group
National Quality Forum's"Safe Practices for Better Health Care"

Tags:
health care quality
patient safety
medical errors

Nobels: A new measure of health care quality?

I'm not an economist, but living in Washington, DC, I know at least as many economists as I do lawyers. I always find it interesting to hear what economists have to say about health care.

Thanks to the Health Behavior News Service blog for pointing me today to an article in the New York Times (Oct. 5, 2006) by Tyler Cowen, professor of economics at George Mason University, on innovation as a measure of health care quality, and spinning off into other musings about health care policy. I'm tempted to post a line-by-line point-counterpoint, but I'd surely end up violating fair use guidelines. And unfortunately the article just went into the archives for which you need to pay (or get a free 14-day subscription)... so I hope you'll trust me to quote and paraphrase Cowen correctly.

Cowen starts off by reiterating what we all know by now: that health care in the United States isn't all it's cracked up to be. Fine. He immediately goes on to say that "the American health care system may be performing better than it seems at first glance," because we're leaders in innovation, as evidenced by the number of Nobel prize winners in the U.S. Beg pardon? When did the number of Nobel prizes become a measure of quality, and how it is even related to the quality of care we do receive? But OK, for the sake of argument, I'll play.

First, is the number of Nobels related to innovation? Cowen goes on to list a number of technologies, most of which appear to be unrelated to Nobel prize-winning work, and in fact, began in other countries, though they have some connection to the U.S., who are "leaders in converting new ideas into workable commercial technologies." Leaders? No evidence given, but let's move on to the next question: are they workable commercial technologies? Sure, lots of hospitals have MRI technologies, CAT scanners, mammography units, and balloon angioplasty technology. ACE inhibitors are well accepted for treating heart attack victims. "Workable commercial technologies"? What does that mean? That someone can send you a bill for using it? OK, commercial I'll accept, but the next step is to look at the relationship between innovation and quality. First you'd have to assume that the innovations become part of health care. As my regular readers know, it ain't necessarily so.

Cowen describes the huge imbalance in US spending on health research compared to that of Europe, and then says something I simply don't follow:

About 400,000 European researchers are living in the United States, usually for superior financial compensation and research facilities.

This innovation-rich environment stems from the money spent on American health care and also from the richer and more competitive American universities. The American government could use its size, or use the law, to bargain down health care prices, as many European governments have done. In the short run, this would save money but in the longer run it would cost lives.

We seem to have gone from spending on research to spending on health care. How are these related? Cowen never explains. Somehow, though, he's suddenly slamming health care price control negotiated by European government, and because "in the longer run it would cost lives." Again, I have no idea what he's talking about, and this is much too important a point to leave hanging there unsubstantiated.

Moving right along. Cowen cites recent research on the relationship between life expectancy gains and health care spending (also on the dicey side, but I'll let it slide for now) and then brings innovation back in, saying that the US looks worse than it is relative to other countries not because of innovation, which has diffused to other wealthy countries, but because of lifestyle factors such as diet and physical activity. That may be, but you can't tease those factors apart from the kind of research he cites. However,

the extra money Americans spend to treat allergy symptoms, pain, depression and discomfort contributes to personal happiness.

Thank goodness we get to spend our money on allergy drugs and antidepressants; they'll help us worry less about the fact that we have some of the worst health disparities in the developed world. Similarly,

Sick people receive more momentary comforts and also the sense that everything possible has been done. This feeling is of value to the family even when the patient does not improve. In contrast, European countries have not created comparably high expectations about the medical process. If we count "giving people what they would want, if they knew it was there" as one measure of medical value, the American system looks better.

Oh, my goodness. Is Cowen serious? Can he really think it's ok that we're paying ourselves into trillions of dollars of deficit for the illusion of being well served by health care? European countries may not have created high expectations, but they actually deliver higher quality, more equitable, and, yes, more efficient health care.

Finally, after pointing out a few more of the country's health care deficiencies, he wraps up thus:

These problems should be addressed, but it would be hasty to conclude that the United States should move closer to European health care institutions. The American health care system, high expenditures and all, is driving innovation for the entire world.

I don't know - which system would you choose?

health care quality
health economics

Skeptics' Circle #45

Skeptics' Circle has a new wrinkle this issue: the blog posts are summarized by their own writers in a podcast format (in addition to the listing of links in the page version). All I had to do was download Skype (which I'd been meaning to do anyway), call in to the appropriate number, and dictate my post. To listen, go to the link above, and be sure to click on either the "Higher Quality" or "Very Low Bandwidth" links. Oh, and have some music you like at the ready so that you don't get the Ghostbusters theme stuck in your brain.

Medical blog carnival

Here's a link to this week's medical grand rounds, volume 3.3. Lots of good stuff in here.

blog carnival
medical

Unblocking translational research

The U.S. National Institutes of Health has just announced $100 million in startup funding for a consortium of 12 academic health centers to work collaboratively within and between institutions to accelerate clinical research and to bring new research to practice. This money will go towards developing research informatics tools, training the next generation of researchers, expanding outreach to minority and medically underserved communities, and promoting interdisciplinary research among biology, clinical medicine, dentistry, nursing, biomedical engineering, genomics, and population sciences.

I'm wondering to what extent this effort really reflects what it takes to bring research into practice ("bench to bedside" is almost a cliché at this point, and usually originates at the basic sciences end of research, rather than from the perspective of practicing clinicians, not to mention that quality health care should not stop at the bedside).

Lauran Neergaard, writing for the Associated Press dug a little deeper into what exactly is meant by translation science, and she got some interesting answers. According to Neergaard, NIH Director Elias Zerhouni said that it took a 10-year study (i.e., the Women's Health Initiative, a randomized trial) to overturn the existing belief that estrogen was, on the whole, good for women's health, implying that the current effort towards improved collaborations and networking would do away with such delays. But wait... is he saying that the rapid aggregation of networked information on case subjects would obviate a randomized trial? For example, universities can pool patients to spot drug side effects. But in the absence of an RCT, or even controls, what do these side effects mean? As I've said before, big numbers aren't everything.

Or in other words, as many others have said, the plural of anecdote is not data.

RCTs already function in a centralized and highly networked fashion; perhaps these awards could add functionality to interinstitutional collaborations, but I doubt it would eliminate the 10 years required to accumulate meaningful health outcomes such as the ones we needed to see in the Women's Health Initiative. Or am I missing something here?

Next, where is the health systems aspect? Neergaard also interviewed Robert Califf of Duke University (one of the institutional award recipients), who pointed out that some of the money will be used to study why practitioners don't always follow proven strategies. Now we're talking. But it's not just the practitioners - and since we know that simply handing practitioners new information doesn't get them to change their practice, we need to look at the larger systems within which practitioners operate, and what the various helps and hindrances are to providing quality care.

The interdisciplinary efforts described don't mention systems science, behavioral sciences, or economics. And much of what's needed in closing the quality gap involves increasing the use of established research. I'd advocate for big-picture oversight to make sure that gaps are being systematically identified and filled, and that the taxpayers' money funding this stuff is being put to the best use.
health care quality
translational research
national Institutes of Health

Weekly this and that

Potential downsides of supplements

Thanks to The C.A.M. Report for leads to new studies of harmful effects of dietary supplements in AIDS patients. The blog post refers to studies that are not necessarily of high-quality, point again to the need for high quality studies of widely used and pricey supplements that might not be as benign as their purveyors and their shills would like us to believe.

Healthy aging in the news

New York Times health reporter Gina Kolata has a great article in today's Times about mental and physical aspects of preventing frailty in the elderly. She manages to tell the story of the ups and downs of the research in full context and without getting into the nitty gritty of study designs and other research jargon, and without making wishy-washy health recommendations (e.g., "If you'd like to find out more about how you can prevent disease X, talk to your doctor.") [Disclaimer: I have worked with Gina Kolata and two of the researchers quoted in the paper, and have done original research with them on related issues. Overall, it's a subject I'm pretty passionate about, and one of my career goals is to help old people keep walking.]

Headline abuse

"New study finds chocolate chip cookies lower cholesterol" - not.

Sorry, they don't mean Entenmann's or Chips Ahoy. Guess what? This is an ad (complete with prices and ordering information) disguised as a press release, posted on EurekAlert, a free service that disseminates research press releases. The cookie, um, researchers provide some of their study methodology, but of course are selective about reporting the results; I don't know if they even bothered to look at side effects. The cookies (made with psyllium and plant sterols - yum!) are basically dietary supplements, about which the press release authors are making a health claim. I may even see if I can track down someone at FDA who might give a hoot.

The reason I chose this item and dignified its title by calling it a "headline" is that whoever wrote it was clearly hoping that some unwitting health writer would pick it up and use it for just that purpose. So writers, if you're reading this, don't pick up the bait (as I did).

There's flu, and then there's flu

I won't get into this at length here, but I'm sensing a disconnect: the media covers the progress of bird flu almost every day, to the extent that experts are warning us not to forget about big killers like TB and AIDS, and Americans don't plan to get a flu shot because they're not really worried about it. Yet the standard flu kills tens of thousands of Americans every year, while bird flu has killed a lot of birds and a handful of people worldwide, and although it's potentially more lethal and we don't have a vaccine for it, it can't jump from human to human - yet.

I don't know, maybe it's all about that "yet." Has anyone asked people - or health journalists and editors in particular, for that matter - whether they would get the bird flu vaccine should it become available?

EDIT: The George Washington School of Public Health grand rounds series hosted a conference this week entitled "Synergized reactions to avian and pandemic influenza"; you can access the webcast here; thanks to Kaisernetwork.org for hosting the webcast (podcast also available).

Medical blog carnival

Don't look for my posts here yet, but this weekly carnival summarizes good blogging from docs (and others interested in medical topics) around the world. If all goes well I'll be hosting one soon.
flu
dietary supplements
aging
health news
prevention