6 people in the active arm of the study. Unpublished data. Everything comes from the company. Even investors reading a business story deserve better than this.
You can cover tiny studies like this but you need to do so with caveats, context and discussion of limitations. Those didn’t appear in this story.
It’s Alzheimer’s Disease, for which there are no effective treatments. That’s why it matters to put preliminary findings in proper context, rather than trumpeting unspecified benefits from a short-term trial of 6 people.
The approach is not yet approved in the US, so it’s understandable that costs here were not included. The story did note that “In Israel, the treatment costs $6.000.”
But we aren’t certain what exactly is the definition of “treatment.” Is that in total or for each session? According to the company’s website, patients receive daily treatments, five days a week for 6 weeks to start. At $6,000 per session (in Israel) that is $180,000. The published proof of concept study (http://www.springerlink.com/content/27622j8188653442/ ) suggested the need for twice a week treatments for an additional 3 months. That is another $144,000 if the cost is as described. So, is the cost $6,000 or $324,000?
The way benefits were framed in this story is almost a carbon copy of how company-controlled release of data is communicated to the public.
The story quoted the company CEO (!) saying “We see improvement lasting for 9-12 months and the good thing is that patients can return and undergo treatment again. If out of 10 years the patients have left to live we can keep them at home in a relatively mild state of the disease for three, four, five years, it’s a lot.”
How many see improvement lasting 9-12 months? All of them? (Later in the story, an investigator said only 6 patients received the real treatment (!) and all showed cognitive improvement.)
How is “improvement” defined and measured?
You also have to read the piece carefully. The “treatment” does not include just sitting in a chair. It also includes unspecified cognitive training. Since the study design is not noted we don’t know if there was a control group or a group who simply received cognitive training without the use of transcranial stimulation.
We can’t know how complete is the list of complications reported when the data haven’t been published yet and we’re hearing this only from the company and/or a company-supported investigator. The story stated that “about 20 percent of patients experience a mild headache but there are no long-term negative effects.” Why would this approach cause headaches? How can you discuss “no long-term negative effects” after short-term results in 6 people?
The story should have painted a picture of how incomplete the harms picture is at this point.
The story finally revealed that only 6 patients got the actual treatment but never discussed how limited are the conclusions that can be drawn from such a tiny sample.
The story also threw in a line – “Their improvement was significantly more than the average seen in patients taking just medication.” Whoa? What medication? How exactly was this trial designed?
There was no overt disease-mongering of Alzheimer’s disease in the story.
The story only quoted the company CEO and Dr. Alvaro Pascual-Leone. But it didn’t disclose that Pascual-Leone is on the company’s scientific advisory board.
There was no truly independent perspective in the story.
There was no comparison with any other approach for Alzheimer’s disease.
Apart from telling us, “Their improvement was significantly more than the average seen in patients taking just medication,” we are not provided with any meaningful comparison to other approaches.
Mixed bag here.
The story explained that the the device is approved for use in several other countries. But it also said the company “expects the system to be approved by the U.S. Food & Drug Administration in late 2014.”
No basis for that projection was given. Later the story stated that “US trials are expected to run till the end of 2013.”
So the entire projection of approval and availability is based on a hope and a prayer and a crystal ball of unknown clarity and certainty.
The story quotes Dr. Pascual-Leone saying “The application in Alzheimer’s disease and in combination with cognitive training is novel.”
It may be novel but this group is not the first to develop a therapeutic use for TMS (FDA approved device is available for the treatment of depression) and other groups have demonstrated small but reproducible effects of TMS in patients with Alzheimer disease. (see, http://www.ncbi.nlm.nih.gov/pubmed/19049544)
So the lack of clarity about exactly how “novel” this approach is leads to rule this unsatisfactory.
There’s no evidence that the story relied on a Neuronix corporate news release, even though the story still relied on company management or -funded spokesmen and still read like a news release.