Paul Kedrosky surfaces this bit of good news from a (subscription-required) Wall Street Journal article:
NIH Director Elias Zerhouni said the voluntary policy encourages scientists who receive full or partial NIH funding to submit their research papers to a database that will be run by the agency.
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The policy asks scientists to make their work freely available on the NIH's PubMed Central database "as soon as possible and within 12 months of final publication" in scientific journals such as the Journal of the American Medical Association and the New England Journal of Medicine.
We should all applaud this move. But if John Abramson is right, it's only the first step in a very long journey. His book Overdosed America: The Broken Promise of American Medicine is a searing indictment of a process so corrupted by pharmaceutical and medical-equipment interests that, Abramson says, we now have on our hands:
...a scandal in medical science that is at least the equivalent of any of the recent corporate scandals that have shaken Americans' confidence in the integrity of the corporate and financial worlds.
Abramson, who was a family doc for two decades, brings a potent arsenal of additional perspectives to his analysis:
I'm going to quote liberally from the book because I want to put some of this material into circulation (and because I am was on a long flight).
On reading medical journal articles that didn't add up:
When I finished analyzing the article and understood that the title didn't tell the whole story, that the findings were not statistically significant, and that Pravachol appeared to cause more strokes in the population at greater risk, it felt like a violation of the trust that doctors (including me) place in the research published in respected medical journals.
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The purpose of this article seemed incontrovertible: to establish "scientific evidence," legitimized by the prestige of the New England Journal of Medicine, that would lead doctors to believe that they were reducing their patients' risk of stroke by prescribing Pravachol. The collateral damage in establishing this belief is the diversion of doctors' and patients' attention away from far more effective ways to prevent stroke and achieve better health.
On closed-source research:
In retrospect I can see that these two articles on stroke reduction, for all their flaws, had at least presented enough data to allow the commercial sleight of hand to be uncovered by careful analysis. I was soon to learn that this is not always the case.
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One might assume that anyone who was willing to go to the trouble of verifying the conclusions presented in medical journals could do so. This is not the case at all. Drug companies often keep the results of their studies secret, even from their own researchers, on the grounds that such results are "proprietary information" of economic value.
On finding raw unpublished data:
I started with the Harvard Medical School's digital library, but couldn't find any new research or more complete data. Next I tried the government-sponsored "Pub-Med" website, a database of several thousand scientific journals; but a comprehensive search there didn't yield any new information either. Then I went to the FDA website to see if I could find any unpublished data...
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As I started to go through these reports I realized that they were the actual FDA reviewers' internal analyses of the research data that the manufacturers of Celebrex and Vioxx had submitted to the FDA from the CLASS and VIGOR studies. I could not believe what I was seeing. The FDA reviewers' reports contained a treasure trove of "not-yet-spun" data, revealing a very different picture of the safety of these two drugs than had been presented in the JAMA and NEJM articles.
On the effects of spinning the data:
By the end of 2001, 57 percent of all money spent on prescription arthritis medication in the United States was spent on Celebrex and Vioxx, and both were among the top 10 selling drugs in the United States. My research into statins, and now Celebrex and Vioxx, was showing that what was being presented by the most trustworthy sources as the best medicine was quite often the opposite, and that the commercial distortion of our medical knowledge had become a major impediment to good medical care.
On the myth of excellence:
An extensive comparison of the health of the citizens of industrialized countries done by the Organisation for Economic Co-Operation and Development (OECD) confirmed the conclusions presented in Dr. Starfield's article. The United States again ranked poorly, with 18 industrialized countries having greater life expectancy.
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The U.S. health care system is clearly alone among the industrialized countries. The following chart shows that Japan and Switzerland stand out for their good health, and the Czech Republic stands out for its low cost and poor health. The United States, however, is almost off the chart with its combination of poor health and high costs.
On conflict of interest:
In retrospect one wonders why the NIH and FDA continued to support Rezulin long after it was known to be associated with so many deaths. One particularly troubling aspect of Rezulin's seemingly privileged treatment was provided by David Willman's series in the Los Angeles Times. Dr. Eastman, while in charge of diabetes research at the NIH and overseeing the $150 million study in which Rezulin was included, was receiving $75,455 from Warner-Lambert on top of his $144,000 annual salary from the NIH.
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None of this was part of the public record, but the financial relationship with Warner-Lambert had been approved by two of Dr. Eastman's superiors. And Dr. Eastman was by no means alone. In fact, the Los Angeles Times reported that no fewer than 12 of the 22 researchers who were overseeing the $150 million government-sponsored diabetes study as "principle investigators" were receiving fees or research grants from Warner-Lambert.
On supply-side medical care:
Post-heart attack care has changed dramatically since the early 1980s, when only about 10 percent of heart attack patients in the United States underwent diagnostic cardiac catheterization. By 1998, more than half of our heart attack patients were receiving this diagnostic test, with more than half of these going on to angioplasty or coronary artery bypass surgery.
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On a per-person basis for patients of all ages, the United States does three and a half times as many coronary angioplasties and coronary artery bypass surgeries as the other industrialized countries. One might conclude that this investment in the treatment of heart disease in the United States and increased longevity for heart attack victims is proof positive of the superiority of our treatment of heart disease, end of story.
Not so, according to data from the National Heart, Lung, and Blood Institute of the National Institutes of Health. The United States has the third highest death rate from coronary artery disease among 10 wealthy industrialized countries.
On direct-to-consumer drug advertising:
The explosion of drug ads in the 1990s was exquisitely coordinated with the transition of large numbers of Americans to health plans that covered the cost of prescription drugs.
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[You should] immunize yourself from the drug companies' efforts to convince you that you desperately need their advertised products. If you really needed the product, it is unlikely that the drug companies would be spending money on advertising. Remember, there aren't many ads for insulin on TV.
There's lots more but we're pushing the boundaries of fair use so I'll stop here and make my point. Abramson thinks we can save billions of dollars a year, while at the same time improving the quality of health care in the U.S. How? By reforming the system that creates and disseminates medical knowledge -- a system that he argues has been corrupted on an Enron-like scale.
To drive that reform, Abramson proposes a Federal Reserve-like regulatory body. I'm skeptical about that, and so are these critics interviewed in Managed Care magazine, which ran an interview with Abramson in January. According to David B. Nash, MD, chairman of the department of health policy at Jefferson Medical College in Philadelphia:
"What we are lacking is an in-depth conversation about the shared values that should be driving our system," Nash says. "That conversation should include political as well as scientific leadership, and has to address equity and access."
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"But until this conversation is conducted on a national level, we're going to have the kind of problems Abramson and others are considering quick fixes for," says Nash.
Although I'm pretty sure that Abramson and Nash don't realize it yet, the blogosphere stands ready to enable that conversation. What blogging is doing for mainstream journalism and general knowledge must now be recapitulated in the realm of health care. The crucial players will be analysts and policy wonks like Abramson and Nash, medbloggers, and citizen bloggers.
Abramson is clearly Internet-savvy, though not yet a blogger. If and when he becomes one, he can expect to be engaged in a lively discussion that will challenge, and ultimately help to sharpen, his arguments. For example, on page 47 the book uses a chart to illustrate the assertion that the U.S. "is almost off the chart with its combination of poor health and high costs." I wanted to reproduce that chart but, though I found an image of the page using Amazon's "search inside" feature, the chart was garbled there. So I went to the raw data that Abramson helpfully cited here and here. From these data I was able to create (a version of) the chart that appears in the book:
In order to do so, I had to combine both of the cited sources: the OECD's per-person expediture data and the WHO's healthy life expectancy data. If you instead use the OECD's raw life expectancy data you get a chart that looks like this:
The U.S. is the clear cost outlier on both charts. The first chart, however, places us near the low end of the life expectancy range, justifying Abramson's assertion that we combine "poor health and high costs." The second chart places us near the high end of the life expectancy range, suggesting that while value still isn't proportional to cost, we're at least buying more value than the first chart indicates.
Different definitions of life expectancy produce these different views. Abramson writes:
One of the best single indicators of a country's health was developed by the World Health Organization (WHO); it is called "healthy life expectancy." This measure represents the number of years that a child born now can expect to live in good health (i.e., total life expectancy minus years of illness adjusted for quality of life). Children born in the United States today can expect to live the equivalent of about 69.3 healthy years of life, while children born in the other 22 industrialized countries can expect an average of 2.5 additional years of healthy lifeThe first chart uses this measure of life expectancy. The second uses the raw numbers. Has Abramson spun the data to make his point, just as he accuses the pharmaceutical industry of doing? Of course. Everybody spins the data. What matters is that:
Former URL: http://weblog.infoworld.com/udell/2005/02/07.html#a1169