August 14th, 2008 by David E. Williams of the Health business blog
I’m a big fan of the Wall Street Journal, which I’ve always found heads and shoulders above any other business news source, so naturally I have been concerned about what will happen to it under new owner Rupert Murdoch. I’ve tried to keep an open mind and so far I’d say Murdoch has improved the paper overall. There’s more non-business news and more independent analysis than before, which is great.
But I was really excited and heartened by the story I saw today, tucked away at the bottom of page B1: Boston Scientific Study Flawed. As I started reading the article I noticed that something was different. What was it? When I got to the ninth paragraph and encountered the first quote (from Boston Scientific’s chief scientific and medical officer) I realized what the Journal was up to: Not the usual reporting on what the New England Journal of Medicine had printed the previous today or what some scientist had said at a conference or what some think tank had come up with, but the Journal’s own, independent analysis.
The issues raised are hard-hitting and direct:
- That the Wald equation used by Boston Scientific in the Taxus Liberte Atlas study –and also used by Boston Scientific’s rivals– is a flawed measure
- That using any other measure would have rendered the study a failure “by the common standards of statistical significance in research”
- That non-inferiority studies like this one aren’t a particularly high standard to meet
- That omission of a control group biases the study in Boston Scientific’s favor
Here’s a taste of the Journal’s critique:
In a vital part of its calculation, called the “standard error,” Boston Scientific assumed that the difference between the true rates of reclogging between Liberte and Express was one percentage point-what the trial showed. In a sense, the company’s equation assumed that Liberte definitely isn’t inferior. That’s a problem, since the equation was supposed to be deciding whether Liberte might be inferior after all. As a result, Boston Scientific’s equation gives wrong answers that consistently favor the Liberte.
To remove that flaw, the standard-error calculation should be modified so that it assumes the true difference between rates is three percentage points. When done that way, the chance falls above 5% — meaning the results failed to reach statistical significance.
In typical Journal style, the article is fact-based and neutral in its tone. It doesn’t include loaded terms or use “experts” to act as proxies for the reporter’s personal opinions. I’m sure the Journal will publish letters that it receives in response and that they won’t all be patting the paper on the back the way I am.
I think this type of reporting is great, and much needed. It’s hard to find trustworthy, unbiased sources of medical information these days. Device and pharmaceutical companies have an obvious bias in favor of their products, researchers are influenced by fees they receive from the companies, medical journals are heavily supported by industry revenue, payers are focused on cost control, and the FDA is understaffed and limited in its freedom. We need another voice and I’m glad the Journal is providing it.
I had a look at the comments on the topic at the Wall Street Journal’s Health Blog. A few praise the coverage, but others are skeptical. Issues include: who supplied the data, why didn’t the Journal raise the issue when the study came out, what about the Journal’s own bias toward its advertisers, and a couple of people who say this is a whole lot of fuss about nothing. I’m all for the debate –and say thanks to the Journal for enabling it to occur.