Life Saving Devices May Put Your Life in Danger
Reports of conflict of interest in clinical drug trials, as well as unsafe drugs that make it onto the market (most notably the case of Vioxx), have brought increasing attention to corruption and lack of regulation in the pharmaceutical industry. Recently, the medical device industry has come under similar fire for corporate profits outweighing public safety.
In late July, the Institute of Medicine released a consensus report and letter to the FDA, detailing the limitations of the FDA’s system for approving medical devices. Currently, devices deemed “moderate risk” do not undergo clinical trials and companies need only assert that their devices are “substantially equivalent” to previously cleared ones. This system creates chains of devices that are all supposedly safe, but in some cases the first link is to a device that is no longer available – or that was never proven safe to begin with.
“Moderate risk” devices include some, like pacemakers and artificial hips, that can cause serious harm. The complaints against Medtronic’s all-metal artificial hip, for example, continue to pour in with over 7,700 filed so far. Many people have faced severe injuries or have had to undergo additional surgery to have the product removed.
Another upsetting story by Dan Walter shows that the failure lies not just in the FDA’s process, but also in medical conflicts of interest. Walter’s wife was enrolled in a study of Johnson & Johnson’s Biosense Webster Lasso Mapping Catheter. But a device error, combined with misuse by the cardiologist, left Walter’s wife at death’s door. She required immediate open heart surgery, after which she suffered a stroke and remained comatose for three weeks.
The catheter had already been approved as substantially equivalent by the FDA and so the study, led by Johns Hopkins doctor Hugh G. Calkins – paid adviser to Johnson & Johnson – was solely intended to gather data. Walter explains, "Although the study was set up to gather data, it was not considered a clinical trial and therefore was not subject to ethical guidelines for clinical trials or oversight by an institutional review board." Calkins admitted that the device was at fault, yet it remains on the market today.
Changes in FDA regulation of medical devices might also bring attention to genetic testing, also classified as a “moderate risk” medical device and a topic often covered on Biopolitical Times.
The FDA will hold hearings on the Institute of Medicine report soon. But we need to anticipate the powerful lobbying efforts of the medical device industry that will work to keep the current system in place. Let’s hope the FDA focuses less on corporate profits and more on ensuring that medical devices actually improve health and save lives.
Previously on Biopolitical Times: