This story shows how "a shortcut the Food and Drug Administration allows for granting regulatory approval to certain medical devices" has allowed the NanoKnife, an experimental treatment with very limited evidence, to be touted as the latest cure for cancer. The story hits nearly all of our marks, although we wish there were more detail in areas such as costs, potential benefits, and the overall evaluation of the evidence.
This device is the type one might see advertised on the side of a bus or in the back pages of of a weekly tabloid. Health reporters often ignore these claims to focus on the higher profile blockbuster drugs being sold by major drug companies or some breakthrough discovery in a major scientific journal. The promotion and use of these under-researched devices can have devastating consquences for patients. In addition, one of the major drivers of increasing health care costs is the introduction of new technologies. While additional costs may be justified if there is an improvement in patient outcomes associated with the new technology, newer is not always better. The NanoKnife is the latest in a series of new devices, approved by the FDA, that have yet to demonstrate a substantive improvement in patient outcomes. Hospital promotion of new technologies is now rivaling that of other commercial interests with unsubstantiated claims.
The story says that each machine "costs as much as $300,000." It does not provide a per-treatment cost, which would have been nice. It does say, though, that "Medicare doesn’t specifically pay for use of the NanoKnife, though hospitals and doctors get reimbursement under more general medical-treatment billing codes. Some private insurers, including Arkansas BlueCross BlueShield, decline to cover its use because of the lack of "scientific evidence of effectiveness in improving health outcomes.""
As with the harms, it is difficult to quantify the benefits because of the lack of evidence. Here we think the story relies a little too much on anecdotal evidence. On balance, the story presents a complete picture, though.
Because of the lack of evidence, it is difficult to quantify the harms. But the story did a nice job of addressing the harms. "Some side effects have been reported. Because the device uses large electrical bursts, it can trigger fast heartbeats. Four such cases out of about three dozen patients were described in a recent report by Ken Thomson, a radiologist in Melbourne, Australia. AngioDynamics says that these cases have all been treatable and that the company has taken technical steps to minimize such future occurrences. One case reported to the FDA was of a U.S. patient who in July suffered a serious hemothorax, or blood buildup between the chest wall and lungs. The patient had to stay in the hospital for 16 days, and doctors said an artery "most likely" was punctured during the operation. AngioDynamics said in the FDA report that such a puncture is a "possible complication" of any such operation." This is more detail than is provided in most stories, even when there is much more evidence available.
The entire reason for this story is to evaluate the disconnect between the claims being made for these machines and the lack of evidence to support those claims. It does a great job walking readers through the way the machine is supposed to work, the health benefit claims and the paucity of credible evidence for the machine’s benefits. One quibble: AngioDynamics says that the machine has been tested in "small number of human patients". What were the results? Why does the company think the results are promising?
This story does not engage in disease-mongering.
The story quotes a number of outside experts, including Riad Salem, chief of interventional oncology at Chicago’s Northwestern Memorial Hospital; Ken Thomson, a radiologist in Australia who studied the devices; and Tim Clark, director of interventional radiology at Penn Presbyterian Medical Center in Philadelphia. Importantly, the story also makes the distinction between the claims the company is making and the claims being made by the clinics and hospitals who have bought the machines (and are trying to recoup their investments.) It quotes the CEO of the machine manufacturer saying, "We are not part of the whole PR machine. It’s not something we are happy about."
The story does not do a very good job of contrasting this treatment with other treatments. This is disappointing because one of the claims made by the manufacturer’s CEO is: "We think this is a very promising technology for treating cancer that is otherwise untreatable." Some specifics about those cancers and how they are otherwise treated would have been nice. Because the NanoKnife has not been compared to a more traditional surgical approach, the benefits of the new technology are hard to define. Unfortunately the story relies on a biased statement by the CEO of the manufacturer as its sole comparator.
The story says that the NanoKnife is "currently being used in about 13 U.S. hospitals including Baptist Health Medical Center in Little Rock, Ark., University of Louisville, and Shands Hospital/University of Florida in Gainesville, Fla." It later says, "The NanoKnife, which is also available in five hospitals outside the U.S., has so far been used to treat about 300 cancer patients world-wide."
The story makes it clear that similar devices have been used for other procedures, but that this is a relatively new therapy for cancer.
This story does not rely on a news release.