Wednesday, March 01, 2006

More About Guidant: "It Is Possible That Physicians and Others May Pull On These Threads"

The New York Times is continuing to investigate the operations of Guidant Corporation. We have previously posted quite a bit about Guidant in the past, focussed on its history of withholding information about possible adverse effects of its devices. (For our more recent posts, go here, here, here, and here.)

The Times' most recent article focuses on newly released documents from an ongoing court case against Guidant. Some key quotes:

As the Guidant Corporation came under scrutiny last spring for not telling doctors about potentially fatal defects in its heart devices, the company's public message was upbeat and insistent: concerns about the safety of its products were overblown, it said, and perhaps even irresponsible.
But newly released documents show that, inside Guidant, executives were struggling to contain a mounting crisis.
The company's crisis started last May after two doctors in Minneapolis, Dr. Robert G. Hauser and Dr. Barry J. Maron, learned from Guidant executives that an electrical flaw in a company defibrillator had played a role in the death two months earlier of a college student who was their patient. They urged the company to alert doctors about the potential of the device, the Prizm 2 DR, to short-circuit. When Guidant hesitated, they contacted some other doctors and The Times.
Mr. [R. Frederick] McCoy [Jr., President, Cardiac Rhythm Management] struck an upbeat rallying tone in many of his messages. After The Times article about the Prizm 2 DR appeared, Mr. McCoy jotted on a note pad: 'Positive proactive visible,' summing up the company's strategy. In another note, seemingly dismissing the problem, he wrote, 'Nobody calling our decision and action into question.'
But even as Guidant was assuring doctors that it did not plan to recall the device, executives inside the company were less sanguine. On June 2, for example, Dr. Beverly H. Lorell, Guidant's chief medical officer, sent an e-mail message to Mr. McCoy about other company devices that might attract outside scrutiny. Some data about them, she noted, was in a public F.D.A. database.
'Parts of the data for each of the three trends are in public domain and thus amenable to further external scrutiny and discussion,' Dr. Lorell wrote. 'It is possible that physicians and others may pull on these threads in the near future.'
As those threads began to unravel, executives like Mr. McCoy soon found themselves backtracking.
Strikingly, some Guidant executives realized early, according to records, that the crisis might be contained if the company overhauled its disclosure practices and provided doctors with more detailed failure data. But a draft press release, dated June 3, shows that Guidant planned to combine the announcement of such a policy change with a marketing initiative to promote a new product. The release apparently never went out, and five months passed before Guidant issued its new and detailed report on product failures.

It is striking that although some Guidant managers thought that a transparent approach to releasing data about possible product flaws might be best for the company, those in charge circled the wagons.

To make important medical decisions, like those about implanting cardiac devices, patients and physicians need accurate, unbiased data about the possible benefits and harms. Withholding data about the possible harms caused by devices is bad for patients, a threat to physicians' professionalism. And ultimately, it appears to be bad for device makers' bottom lines. (The Times article noted that Guidant's market share for cardiac devices has fallen from 35 percent to 24 percent.)

So, instead of tying up all the threads in secret cloths, health care organizational leaders need to pull on them themselves.

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