According to a story from Dr. Hooman Noorchashm, the US Food and Drug Administration (FDA) has a reasonably effective system for regulating and approving new drugs while appropriately evaluating them for safety concerns. However, there is a serious lack of regulatory oversight when it comes to medical devices and their use for the treatment and diagnosis of cancer.
One Mistake Can be Lethal
Even the least dangerous, most curable forms of cancer can become deadly if not accurately diagnosed or treated effectively. This means that the devices that are used for these purposes should undergo rigorous testing to confirm their effectiveness. They do not. Many medical devices used to treat cancer are essentially introduced to the field in the whim of doctors without any requirements for prior testing or data gathering.
Any mistake made as part of diagnosis or treatment has the potential to mean the death of the patient when cancer is involved. It is a fact that patients have unwilling received treatment or diagnosis with medical devices that have worsened their disease and ultimately led to a death that could have been preventable.
Power Morcellator, a Dangerous Killer
Take a device called the Power Morcellator as an example. It was actively used in the medical field for nearly 20 years. The device caused uterine cancer in women to advance in stage and metastasize. The device, subject to next to no regulation, is likely responsible for the deaths of thousands of women with uterine cancer. In a similar vein, several devices intended to allow for “minimally invasive” hysterectomies for women with cervical cancer directly led to many avoidable deaths over a period of 15 years.
Bad Actors, Bad Devices
With minimal regulatory infrastructure for medical devices, similar disasters are just waiting to happen. The next new medical device could be another killer of unsuspecting patients. It is completely fair to blame, first and foremost, the developers of such devices who are content to allow them for public use with minimal safety verifications. After all, more regulations could cut into precious profits.
Doctors should also share some of the blame here because of their apparent willingness to use untested devices when treating cancer.
The FDA is also partially to blame for the situation. The fact that they knowingly have done nothing to resolve this glaring problem is a serious failure on their part. Perhaps this is another unfortunate sign of infiltration of the agency from device and drug developers.
