Posted by: Salvatore J. Zambri, founding member and senior trial attorney.
In 2005, the Food and Drug Administration (FDA) approved a humanitarian exemption for use of tiny brain stents for patients who were at high risk of suffering a second stroke. The wire mesh brain stents were inserted into the brain arteries of high-risk patients in an attempt to remove blockages and prevent strokes. The original trial involved 45 patients, but did not include a control group for comparing how well the stents worked. Encouraged by those results, surgeons inserted thousands of wire stents into patients.
The subsequent trial included 450 patients in a rigorously controlled study. As recently reported in the New England Journal of Medicine (NEJM), after conducting a multi-center clinical trial, the following statistics became evident:
- “For stent patients:
- 15% had a second stroke or died within 30 days of starting treatment.
- 20.5% had a stroke or died within a nearly one-year follow-up period.
- For non-stent patients:
- Under 6% had a second stroke or died within 30 days of starting treatment.
- 11.5% had a stroke or died within a nearly one-year follow up period.”
Co-principal investigator Colin P. Deredeyn, MD, of the Washington University School of Medicine in St. Louis, said:
“The complications on the stent side of the trial were higher than we expected. Further research may identify specific groups of patients who may benefit from these stents, but for now we seem to be able to save more lives by aggressively working to lower blood pressure and cholesterol.”
Dr. Derereyn went on to say:
“An earlier study found that high blood pressure and cholesterol levels in this group of patients was strongly associated with increased stroke risk. We developed ‘aggressive medical management’ protocols that asked treating physicians to work hard to bring patient blood pressure and cholesterol into safe ranges. We also regularly monitored patients to see if these goals were being met.”
“We only accepted patients whose stenoses blocked 70% or more of an artery, so this was a very high-risk group. While we were selective in that regard, we did not investigate the nature of the blockages – for example, how much of the blockage was plaque only and how much of it was blot clot on a plaque. These patients may have different risk of stroke with stenting.”
As summarized in an editorial by the New York Times, “This case raises the question of whether the FDA should demand more rigorous trials before a device is granted a humanitarian exemption. It clearly shows the value of conducting rigorous controlled studies with enough patients to provide meaningful results.”
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About the author:
Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the ” 2011 Trial Lawyer of the Year“. He has also been acknowledged by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as “one of Washington’s best–most honest and effective lawyers” who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the “Best Lawyers in America” by Best Lawyers, and has also been repeatedly named a “Super Lawyer” by Law and Politics magazine (2011)–a national publication that honors the top lawyers in the country.
Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.
If you have any questions about your legal rights, please email Mr. Zambri at email@example.com. You may also reach him at 202-822-1899.