There was too much gee whiz and not enough hard analysis of the evidence in this piece about a journal article showing that a new eye implant has improved the vision of three people, at least temporarily. While the piece was well written and did a good job explaining the mechanics of the device, there were dozens of unanswered questions about the study itself and about the implant’s broad application.
Retinitis pigmentosa and macular degeneration are two of the major causes of loss of vision in the world today. Given the failure of any drug therapy to halt the progression of either and the lack of progress of gene based treatments, the promise of artificial devices holds a great deal of appeal for the average reader. Researchers have been working on several fronts to improve vision impairments, and the public has seen a series of stories about “breakthroughs” that promise the hope of restoring people’s vision. Wired Magazine in 2002 featured a story with the headline, “A half century of artificial-sight research has succeeded. And now the blind can see.” Yet, where are all the people walking around with bionic eyes eight years later? Stories about devices like the one described in this case and other methods being tested need to take the hype down a notch and make it clear to readers how difficult it is to translate these technologies into an effective, commonly used clinical application. Unfortunately, this story uses a time honored approach of hyperbole in its reporting of this early stage research.
The story makes no mention of costs. Instead by saying, “could be on the market and available for thousands of patients in about five years’ time” it leaves readers with the impression that cost is not an issue. This is exactly the kind of device that an insurance company might put on its “ineligible” list. A quick review of the business media suggests the cost of the device will exceed $75,000 if it becomes commercially available. according to this Medical Device Technology Alert. It is hard to imagine why this important fact was overlooked in the story.
Beyond saying in the lead that three people were able to “see shapes and objects,” there is not much else in the story to help readers understand the levels of vision improvements that were seen and how those should be compared to the preexisting conditions or other treatments. Then, confusingly, the story narrows its focus to just one patient saying, “one blind patient who had the device implanted was able to identify and find objects placed on a table in front of him, and was able to walk around a room independently. He could even read a clock face and differentiate between seven shades of grey, the researchers said. Tests were conducted starting from seven to nine days after the device was implanted.” It’s tough when writing a story about a study this small to put hard numbers to the benefits, but even some acknowledgment of this limitation would have been better than some of the overly optimistic sentiments expressed. The study itself and the press released provided more ways for the story to quantify the benefits.
The story provides absolutely no information on the implant requirements for the device nor the potential downsides associated with this surgical procedure.
There are some caveats tossed into this story, but they can’t overcome the hype. The story says in the lead that the implant “allowed three blind patients to see shapes and objects within days of treatment”. The next sentence says, “Experts described the study results as phenomenal”. The story does deserve credit for saying in the lead that only “three blind patients” saw vision improvement, but the story does little else to describe the limitations of the study or to place it in any context.
The story engages in disease mongering by throwing in some sketchy numbers about the frequency of the disease. It says the device “could eventually change the lives of up to 200,000 people worldwide who suffer from blindness due to a degenerative eye disease called retinitis pigmentosa.” Later it says, “Retinitis pigmentosa in a genetic eye condition that leads to blindness and affects about 1 in 4,000 people worldwide.” By our math, 200,000 out of 6.8 billion people worldwide means that 1 out of every 34,500 people is affected. And if we’re just talking about adults, that number drops to 1 out of every 22,105 people, a far cry from 1 out of every 4,000. If it were truly one out of every 4,000 people worldwide, that would mean that 1.1 million people have the disease.
The story does quote one presumed independent source, Robert Maclaren, a professor of Ophthalmology at Britain’s Oxford University. In the above mentioned Medical Technology Alert, the manufacturer announced that Dr. Maclaren will be the lead investigator on a clinical study expected to enroll six subjects to advance this same retinal implant technology. As a result, Dr. Maclaren can hardly be described as an independent expert. Overall, we felt that the story was missing a strong, independent analysis. Had the reporter talked with more researchers in the field or more clinicians, perhaps the story would have had a more thoughtful tone.
The story mentions that there are other implants, saying, “Other types of retinal implants, known as epiretinal implants, sit outside the retina and because they bypass the intact light-sensitive structures in the eyes they require the patient to wear an external camera and processor unit.” But that’s not a true comparison, nor does it provide readers with the true picture of how much R&D is happening right now in this field. As is often the case in medicine, surgical options and devices are not the only solution. Lowly old Vitamin A is often the first step for treating retinitis pigmentosa.
The story does a credible job noting that the device is under study and not commercially available. Unfortunately it also suggests, based on the manufacturer’s statement, that the device in a very early stage of development will be available in 5 years. The hyperbole used is indefensible – “the device could become routine for some kinds of blindness in five years” and “could eventually change the lives of up to 200,000 people worldwide.” This comes after a test in 3 people.
The novelty of the device is established.
The story does not rely on a news release, and, in fact, this news release from the University of Tubingen contains more interesting information about the study than the story.