This was an incomplete story about a new device which stimulates nerves in the spine to treat heart failure. To be fair, the reporter had a difficult mandate: covering a study which hasn’t been completed yet about a treatment that has never been tested in humans before. But when the evidence base is slim, it becomes even more important, in our view, to communicate the uncertainties surrounding the new approach and to provide a skeptical independent perspective. This story didn’t meet that standard.
The story did contain some useful information. But it failed to address almost all of our criteria – a reflection of our desire to see more caution about the very early state of development for the new device.
(This story was reviewed by two journalists and by a physician – a past president of the Society for Medical Decision Making and a Fellow of the American College of Physicians.)
This story could/should have explained what an early phase I trial means. It could/should have elaborated a bit on the long road to getting to a medical device approved. It could/should have explained that although this is the first patient, it likely would take many years before such a device comes to market and then only if the trials are successful – demonstrating both safety and effectiveness. The patient chosen for this study is clearly in the most advanced stage of heart failure, but there are many effective and life prolonging therapies for earlier stages and not all patients reach his stage. Readers and patients should be aware that there are many effective treatments and that not all patients end up on 7 drugs that are ineffective, and there are lifestyle and dietary changes that are known to be effective. This is not clear from the article – and so – it inadvertently disease mongers.
There was no discussion of costs. With an approach that is this early in its development, we probably can’t expect an accurate price tag on this particular device. Nevertheless, to provide some context, the story could have easily offered information about the cost of similar neurostimulation devices used to treat pain and urinary incontinence.
The story frames the research through the experience of Mr. Hollis Bardwell, the first patient in the study to have a neurostimulation device implanted. The story tells us Mr. Bardwell is "looking forward to rocking and rolling again" — an optimistic outlook that will no doubt serve him well as a patient. But as readers, we want to and deserve to know whether Mr. Bardwell’s enthusiasm is justified, and unfortunately this story doesn’t provide a balanced perspective. As discussed above, the objectives of this phase 1 study are modest and include mostly safety-related assessments. And even if the study does report dramatic benefits for the device on heart function, we won’t know until larger studies are performed whether the results are broadly applicable to other patients with heart failure. By focusing on the experience of one patient and failing to mention the many hurdles that that lie ahead in the development of this device, the story paints an unacceptably rosy portrait of the technology.
No potential harms were mentioned — unacceptable when the whole point of the study being covered is to ensure the safety of the new device. Known complications of implanted neurostimulation devices include wound infections at the surgery site and breakdown of the device or hardware requiring reoperation. Since these devices have never been studied in advanced heart failure patients, we don’t know if these issues might cause more serious problems in these patients than they do in healthier populations where neurostimulation has been tried before.
The story makes it clear that this approach is just beginning to be tested, so there isn’t much evidence to evaluate. But it should have done a better job of explaining why researchers think this approach might work. At one point, the story says there is "considerable data" showing connections between the brain, nervous system and heart, but it doesn’t elaborate or describe this research at all. Elsewhere the story says "the hope" is that neurostimulation will modulate nervous system responses to beneficial effect. But is there any evidence that this might happen — for example from animal studies or from patients with other conditions treated via neurostimulation? Summarizing some of this research would have helped explain the basis for the current study.
Another problem: the story doesn’t provide an adequate account of how the study will be performed and what it will assess. This is a missed opportunity to emphasize the modest aims of small phase I studies, which are primarily about ensuring safety. The story says that the researchers will be conducting tests on patients fitted with the new device "to measure heart function." But according to a description of the study at clinicaltrials.gov, the study will first and foremost be looking at indicators of safety such as hospitalizations, episodes of arrhythmia, and deaths. Discussing these aims in more detail would have provided better context for understanding the research.
The patient profiled in the story is clearly in the most advanced stage of heart failure and may have a dire outlook, but there are many effective and life prolonging therapies for earlier stages and not all patients reach his stage. In addition, it is misleading to suggest that most patients end up on 7 drugs that are ineffective; there are many lifestyle, dietary, and drug treatments that are known to be effective for heart failure. This patient anecdote – coupled with phrases such as "prognosis is grave" and "usually ultimately fatal" – may mislead readers.
The story includes interviews with one of the study researchers and a patient, but it should have tapped someone with no links to the research for an independent take. We’ll flag this one as unsatisfactory.
The story says heart failure is currently treated by oral medications, almost all of which lower blood pressure, and it adds that Mr. Bardwell is on the heart transplant list — another option for advanced heart failure patients. It could have mentioned the availability of the left ventricular assist device, or LVAD, which also can play a role.
Although the story is clear that this treatment is in the early stages of development, It doesn’t give readers a very good sense as to when it might be available to the general public. Paraphrasing one of the researchers, the story states that it "likely will take about a month before doctors have a good idea whether the therapy is working," which might suggest to some readers that it might soon be available after that. Yet this is a phase I study which is primarily geared to assess safety. It is not until Phase II and III studies are completed and successful that companies will go for FDA device approval. This could take many years and the research may never come to fruition. The story never explained this.
The approach being discussed is, indeed, innovative, but we think it’s a stretch to state categorically, as this story did, that "no one" has attempted to take therapeutic advantage of the relationship between the brain, nervous system, and heart before. Research for example has long described a link between depression and heart risks, and some investigators have tried to exploit this knowledge previously by offering psychotherapy or antidepressant therapy to patients with heart disease. There’s also some question about whether this research team is in fact the first to implant a neurostimulation device for treatment of heart failure; a press release issued on July 29 claims another team studying this issue had already enrolled its first patient. Regardless of who was first, the story could have mentioned that other researchers are actively investigating this area.
Although there are some similarities in wording between the story and this press release put out by Methodist Hospital, we didn’t find any exact duplication of text. And since the story includes interviews with a researcher and patient, we can be sure it didn’t rely exclusively on the release for content.