Wednesday, December 28, 2005

"For Guidant, These People Are Just Numbers"

We have also posted frequently about the troubles of Guidant, a manufacturer of medical devices, particularly implantable cardiovascular devices. Recently, we posted that New York State Attorney General Elliot Spitzer has sued Guidant for fraud, charging it concealed defects in its implantable cardiac defibrillators (ICDs, devices that use electric shocks to the heart to attempt to restore normal rhythm). In summary:
  • Guidant has admitted that it did not disclose information about defects in ICDs to doctors and patients.
  • These ICDs are very expensive, costing about $25,000.
  • Had the physicians and patients known prospectively that the ICDs were not as reliable as previously thought, they might have chosen not to implant them, and implanting such flawed defibrillators provided less benefit to the population of patients receiving them than they thought they would receive.
  • Thus, by concealing the information, Guidant likely made more money and increased costs to the health care system, but decreased the benefits to patients.
Last week, the New York Times reported that documents released in connection with another law-suit against Guidant showed that the company was aware by 2002 of flaws, some potentially serious, in the company's ICDs. The company estimated that the failure rate of the devices was about 15 per 10,000, and that about 12% of patients whose ICDs failed would die or suffer a life-threatening event. Yet, perhaps because the company thought that the risks of replacing an ICD would outweigh the risks of device failure, the company did not reveal these estimates.
Dr. William H. Maisel, a cardiologist at the Beth Israel - Deaconess Medical Center, charged, "For Guidant, these people are just numbers.... But for me, these patients are people."
Today, the Boston Globe and the Washington Post reported that the US Food and Drug Administration (FDA) had found "significant violations" at Guidant's Minnesota factory where it makes ICDs. The FDA banned export of the devices or any new uses of the devices until the problems at the factory are resolved. Guidant replied that it had done a "broad, thorough, and systematic review" of quality control and "made substantial steps" in responding to the FDAs findings.
Again, although the failure rate of Guidant's ICDs was low, keeping information about this rate secret prevented doctors and patients from making fully-informed decisions about not only whether to replace already implanted ICDs, but whether to implant such a device in the first place, and if so, whether to implant one made by Guidant.
The principles of evidence-based medicine suggest that doctors and patients need access to the best evidence to make informed decisions about tests and treatments. Suppression of such evidence ultimately will harm patients. We need to make the consequences of such suppression severe enough to deter self-interested leaders of health care organizations from even thinking about hiding or manipulating clinical research.

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