The device called NanoKnife is undergoing scrutiny as a cancer killing machine throughout the United States. NanoKnife uses electrical jolts to zap tumors, but a thorough analysis, including a large clinical trial to prove it is safe and effective in people, has not been conducted.
Currently, 13 United States hospitals including Baptist Health Medical Center in Little Rock, Arkansas, University of Louisville, and Shands Hospital/University of Florida in Gainesville, Florida are using the device. Each machine costs $300,000. And some of the hospitals are aggressively promoting the device in ads and media presentations. In fact, a radio ad developed by the University of Miami’s Sylvester Comprehensive Cancer Center says NanoKnife offers “real hope” to patients with cancer with “almost no side effects.”
Although the NanoKnife has been tested on animals and a small number of human patients, a large, controlled clinical trial has not been conducted. Jan Keltjens, the company executive of AngioDynamics, Inc. of Queensbury, N.Y., the manufacturer of the product, states, “We have not done randomized controlled clinical trials, the so-called gold-standard studies. We think this is a very promising technology for treating cancer that is otherwise untreatable.”
“There is growing concern in the interventional oncology community that the NanoKnife is being widely adopted prior to having gone through the necessary rigors of controlled investigations and clinical trials,” says Riad Salem, chief of interventional oncology at Chicago’s Northwestern Memorial Hospital. Salem says that Northwestern does not have a NanoKnife.
The reason NanoKnife has been allowed to take shortcuts through the ordinary long process of becoming FDA approved deals with a modification enacted in 1976 by Congress. During that time, Congress enacted a change that allows for granting regulatory approval to certain medical devices quickly, often with little or no clinical evidence, if the device is similar enough to another already on the market. This change was allowed in order to encourage innovation in the industry and to get improved products quickly to market. Now, since August of this year, the FDA panel recommends that the regulation be tightened by requiring manufacturers to provide more safety data on new devices and more detail about the connection between new and previously approved devices. Manufacturers have 60 days to comment.
But as a result of the 1976 enactment, the NanoKnife went from being tested in animals to being directly promoted as a cancer fighter. Some fear a situation where the product has been approved by the FDA only to be later recalled due to major side effects. These concerns are based on the Bausch & Lomb Inc.’s situation where its contact-lens solution Renu with MoistureLoc was removed from the world market in 2006 after being linked to cases of fungal eye infection that can cause blindness. Bausch & Lomb was approved through the same shortcut that applied to NanoKnife and was allowed marketing without large clinical studies.
In 2008, NanoKnife was originally approved because it was shown capable of destroying tissue similar to other existing devises that are used in heart surgery. This time around, the NanoKnife is being used to treat cancer by excising malignant tumors near arteries, airways, or other vulnerable tissues and thus difficult to remove.
The device works through disposable electrode needles, which are inserted into the tumor. Powerful electrical jolts are emitted from one needle to the other, creating microscopic holes in the cell membranes of cancer cells. This is what allegedly destroys the tumor, but the large electrical bursts are also what cause side effects such as fast heartbeats.
Tim Clark, director of interventional radiology at Penn Presbyterian Medical Center in Philadelphia, which does not have a NanoKnife, says the device “has potential to treat cancers next to delicate structures.” But for the time being, he says, there is not enough clinical data to be certain of its safety and efficacy.