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Lump of coal for heart stocking story

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Two years ago, I wrote about how the Minneapolis Star Tribune had acted like a cheerleader on behalf of a local company whose product was a mesh-like sock to go around the heart in hopes of combating heart failure.

Over two straight days, the paper reported on the company’s trial results with the sock. The stories did not have one comment from an independent medical source. But they did promote the company’s “bullish” attitude about “the future of their unsual device as well as the company’s prospects.”

When the paper reported on a trial, in which the sock group was compared with a non-sock group of patients, the paper said the sock group scored better in “improvement” (not defined). There was no mention of complication rates. There was no discussion of whether the results were statistically significant, or whether they could have been due to chance.

The Wall Street Journal also reported on the sock study, but pointed out that the “sock didn’t lead to a significant improvement in ejection fraction, the percent of blood that is pumped out of the left ventricle during a beat and a widely used measure of the strength of the heart.”

The Star Tribune coverage felt naive and pro-local-business.

Last week, the cheerleading ended. The Star Tribune was forced to report, “The future of a New Brighton medical technology company remains unclear after a U.S. Food and Drug Administration panel ruled Friday that it may need to conduct a new clinical trial for the firm’s sole product — a unique device that treats heart failure. …The company based its initial FDA application on a 300-patient trial. A similar study, if required by the regulatory agency, could cost Acorn an additional $20 million and take about three years to complete.”

Journalists should review data and evidence and seek independent analysis of ideas in medicine, not local companies’ bullish attitudes about their own products.

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