Sunday, December 26, 2004

Bursting the Balloons

Here's yet another story about how health care executives can hide bad news which might have slowed their cash flow, and then delay taking any responsibility for their actions.
Based on an ongoing grand jury investigation, The Boston Globe reported how Boston Scientific Corporation continued to ship coronary artery stents in 1998 even though its leaders knew that internal testing showed that 10% of the balloons used to insert the stents were failing. During a conference call, the Boston Scientific CEO admitted "we're shipping adulterated product, and we cannot do that." Instead of halting shipments, and recalling stents already shipped, however, Boston Scientific executives decided to "engage" with the FDA to delay a recall. The company also sent a "Dear Doctor" letter reminding physicians to insert the stents using proper procedures, which implied that stent failures were due to incorrect placement procedures. There was no evidence that this was the case. The letter failed to mention the balloons' 10% failure rate, or that Boston Scientific had made changes to the stent manufacturing process that the FDA had not approved. Meanwhile, Boston Scientific was shipping stents worth about $1.5 million a day, and physicians, unaware of these issues, were continuing to insert apparently defective stents from existing stocks.
The criminal investigation of Boston Scientific has gone on for six years without any clear results. The CEO of Boston Scientific, in fact, had predicted that it would be a long time before the company paid any penalty for its actions, "another three or four years and ... Boston Scientific would then settle with a consent decree and a fine."

1 comment:

InformaticsMD said...

While developing a sophisticated invasive cardiology information system for a center performing more than 6,000 invasive procedures/year in this time frame (1996-1998), the COO in charge of IT at the hospital "did not see the value of the data" generated by such systems and fought the effort tooth and nail.

That COO is now the CEO of a major hospital system - one that has a major cardiac treatment facility to boot.

The problems in healthcare will not be improved until the fools and buffoons in its leadership, as well as the outright criminals, are removed from positions of authority.