About 70,000 Boston Scientific Taxus Express2 stents have been used since the product went on the Market last month, and the FDA had heard a couple dozen reports of odd snags, some of which had required patients to undergo emergency open-heart surgery.
A handful of cardiologists were quoted as saying not to worry; another handful were quoted as saying the mishaps were alarming. And the FDA official in charge of evaluating devices said the agency needs more information.
Normally, such articles make for quick skimming, but this time I read every word. A dear family friend was scheduled to receive this very stent, that very morning. I couldnt remember which hospital he had chosen.
And even if a phone call of mine could wend its way through the bureaucracy, I doubted that a frantic message, even armed with The New York Times, could make a difference in a minor surgical procedure. So, I did what many a well-adjusted, professional woman would do.
I called my mother.
By the time phone tag had played itself out, my friend was home and doing well. But my mother, who happens to be a professor of gerontology, had a broader perspective. Various components of permanent and semi-permanent medical devices, say the shellac on a hip replacement, are occasionally discovered to be problematic.
While the message generally gets out to the hospitals and to the doctors, there is simply no way to reach patients, particularly ones who live in rural areas and dont see doctors regularly.
Now, in many cases, notifying patients would be more trouble than its worth. The stent problems occur during insertion, while a doctor is guiding the process. And replacing a hip replacement would require a severe risk.
Still, just this month, the FDA announced a recall of a surgically inserted defibrillator from MedTronic. When its batteries are low, the device may not deliver a heart-rhythm-restoring shock at all or in time.
This month and last brought announcements that patients taking the schizophrenia medicine Abilify (and other atypical antipsychotics) should be monitored for diabetes. Another FDA announcement warns that patients taking certain antidepressants should be monitored for suicide attempts.
Often, the benefits of taking these medicines far outweigh the risks, but patients should know what the risks are—even if they come to light after a doctor writes a prescription.
Anyone with an e-mail account can sign up for safety warnings from the FDA in just a few seconds, but certainly few do. Mechanisms to notify clinicians seem to be moving into place.
The National Institutes of Health and the FDA recently launched a Web site where investigators can report mishaps in gene therapy trials directly to a database called the Genetic Modification Clinical Research Information System (GeMCRIS).
Its not hard to imagine a situation in which search tools and electronic medical records could easily identify patients who should receive warnings. But such power threatens privacy. How easy should it be to draw up a list of the contact information for all patients taking Abilify or for those requiring pacemakers? I hope to speak with the head of the Medical Records Institute about this tension later this week and look forward to learning more.
And perhaps elaborate technological systems to notify patients simply would not do much to improve patient care.
Perhaps thats why people read the newspaper: It turns out that the physician in charge of inserting my friends stent had decided to switch brands.
eWEEK.com plans to discuss this issue with more experts in the coming weeks.