The headline, lede and much of the text of this news release from Rush University Medical Center appear to describe the “first” availability of a “new” electronic device treatment for drug-resistant seizure disorders, but in fact the release is a veiled marketing and clinical trial recruitment document that has the potential to significantly mislead readers. Medical centers, particularly those that participate in multi-center phase 1 trials (the exact case here) must often compete to fill their trial quotas by getting the word out to the general public as well as to referring physicians and specialty clinic staff. We can sympathize with the need. But this release, for the greater part, suggests the microburst vagus nerve stimulator may already be a proven therapy — at least at Rush — for so-called “refractory” epilepsy, when in fact a quick trip to ClinicalTrials.gov points out that it’s a Phase 1 “feasibility” trial to evaluate the “initial safety and effectiveness” of the technology, one derived from earlier versions of electrical brain stimulating devices.
Moreover, although it is technically true that Rush recruited the first patient into the national trial, the emphasis put on the institution’s claim to be the “first” to use it, belies the fact that this is a multi-center trial in which 60 patients at 15 different United States medical centers are participants in the same time frame. Finally, the legitimate news here — that Rush is among 15 medical centers to participate in a study to see if this technology is safe and effective for intractable seizure patients — is missing most of the information people with epilepsy need to see if they might qualify. All in all, this release misses its marks.
A significant percentage of children and adults with particular types of chronic seizure don’t respond — or stop responding — to medications designed to stop or limit their seizures. Vagal nerve stimulators, which stimulate a select area of he brain with electrical impulses, have been used along with medications to help control seizures for nearly 20 years. But the stimulators have limitations and side effects, leading researchers to develop a newer experimental version that uses “microbursts” in a more programmable and targeted way. The newer version may or may not benefit patients compared to older versions and a combination of drug and device treatments. In addition, epilepsy is a collection of seizure disorders, and not every patient is a candidate for this type of treatment. Thus, this phase 1 trial is news, but needs to be put in cautious context until the results are in and subsequent trials demonstrate benefits or harms to particular subsets of individuals.
The price of the implantable devices already on the market are available but nothing is mentioned about costs of the current or experimental therapies.
While the cost of participation in the clinical trial is presumably covered by the trial, the implantation of the device in clinical practice is significant.
There are no results to report since the trial is in the recruitment stage. But even when the phase 1 trial is completed it won’t be capable of supporting benefit claims since it is designed to assess safety and feasibility. There’s a disconnect between the statement that patients “may benefit” and the fact that the study hasn’t been done.
Further, the current success rate of vagus nerve stimulation is in the 50% range and this information should have been included since it’s critical to anyone considering enrolling in the trial.
The release notes that the new study will look at adverse events, but information about the specific harms and failure rates with current stimulator devices should have been included to help place the news of the new trial in some context for would-be recruits.
Given the 25-year history of the use of vagus nerve stimulation for epilepsy, its harms are well known. There is no reason to assume that microburst will be any less traumatic than the currently available approach.
At the least, the release could have explained what kind of evidence the trial is designed to collect, and what kinds of patients, more specifically, the trial centers are trying to recruit. Adults only? Children only? Medical failure history? The exclusion criteria are readily available on the government website, but not mentioned in the release.
No mongering here, but not much information about prevalence of epilepsy, either.
The news release doesn’t mention that the clinical trial is sponsored by the commercial maker of the electrical stimulating device, a serious omission.
The release mentions the availability of electrical stimulators for epilepsy but neglects to note the ongoing research into non-invasive approaches to trigeminal nerve stimulation for epilepsy.
The release describes a clinical trial and not a clinically available device. It could have been much more clear that the device is not a “done deal” instead of implying that the new device is already available, as it does in the first sentence:
“Epilepsy patients who have not responded to standard drug treatments may benefit from a new therapy…”
The release never really makes clear in what way the “microburst” feature is thought to be a better therapy than the electrical pulses used in the conventional stimulator. It just re-states that the study is designed to help more patients with drug resistant seizures. In other words, the mechanism by which the microburst feature might be better is not described in any comparative detail.
As noted above, the lede and headline, along with a good part of the text, overstates the status of the device as a clinical tool, and under-reports the details of the clinical trial that is still recruiting patients. It turns out that Rush was the first to recruit a patient into the study, in February, but saying the institution was the “first to provide the treatment” is misleading. The lede states that patients “may benefit” from the new device and suggests that Rush is the first (and seemingly only) medical enter to have it to offer. Readers don’t learn that 14 other sites will participate in the trial until one of the last few paragraphs.