This safety trial to determine early signs that may lead to glaucoma was carried out on a small number of patients who already had glaucoma and a control group of healthy people. The trial found the test safe in this small group of volunteers but is described in the release with much more enthusiastic language than is perhaps warranted. The release implies earlier detection will reduce blindness but doesn’t explain how.
We also take exception to the claim that “a simple test” could reverse course on glaucoma worldwide. The eye is not a simple organ and there’s no such thing as a simple test. As we’ve been saying for years, whenever you hear the words “simple test” in relation to any serious disease or condition — run for the hills.
Developing a means to detect individual cell death that may be the earliest signs of glaucoma could be an exciting discovery, if there is a strong rationale for early detection.
We cannot assume that early detection automatically translates into better treatments and better outcomes. It can lead to over-diagnosis and over-treatment, and in many cases, the outcome after detecting a disease early is the same as detecting it later on.
Finding early signs of disease in healthy people (before symptoms begin) of glaucoma and other neurodegenerative diseases may not lead to a true medical advance and may just medicalize a patient’s condition without any hope of a cure.
There is no discussion of the costs of the test and the potential costs or cost savings of identifying patients earlier than they otherwise would be identified.
The news release claims that “our developments mean we could diagnose patients 10 years earlier than was previously possible” but what does that mean in terms of disease prevention or reversal?
The release could have put the benefits in context by telling us more about what was involved with the test and how many people were diagnosed with early signs of glaucoma. What were these signs?
The release states only that the initial trials established the safety of the test in patients. The published research says that “ANX776 [the florescent marker or dye injected into patients] was found to be safe and well-tolerated with no serious adverse events, and a short half-life (10–36 min).” If there were non-serious side effects, readers deserve to know what they are.
The release doesn’t tell us very much about the study design. We had to go to the published research findings to learn that the trial involved just eight people with diagnosed glaucoma and eight healthy controls.
It is a real leap from this small open-label safety study to the researcher’s suggestion that “the test also has potential for early diagnosis of other degenerative neurological conditions, including Parkinson’s, Alzheimer’s and multiple sclerosis.”
It has barely established the ‘proof of concept’ in testing glaucoma, so suggesting its potential in other neurological conditions is premature.
There is no disease mongering here. The release provides context on the prevalence of glaucoma and what causes the condition.
The funder is named and we are told that “UCL Business, the commercialisation company of UCL, holds the patents for the technology.”
There are no mentions of alternative methods to screen for early signs of glaucoma.
According to the American Academy of Ophthalmology, the test for glaucoma is not one test but several including measuring eye pressure and cornea thickness, examining the optic nerve and testing peripheral vision, among other steps.
Despite the enthusiasm about its future uses, it’s pretty clear this test is in early trials and unavailable to the public.
The release refers to the tool under development as a “pioneering diagnostic.” A researcher is quoted saying, “Now, for the first time, we have been able to show individual cell death and detect the earliest signs of glaucoma. While we cannot cure the disease, our test means treatment can start before symptoms begin. In the future, the test could also be used to diagnose other neurodegenerative diseases.”
We’ll give the release the benefit of the doubt that the test may potentially be novel for glaucoma but not for any neurological disease for which it hasn’t even been tested.
There is some credulity-stretching language, such as when Bethan Hughes, from Wellcome’s Innovation team, said: “This innovation has the potential to transform lives for those who suffer loss of sight through glaucoma, and offers hope of a breakthrough in early diagnosis of other neurodegenerative diseases.”
The suggestion that early detection leads to prevention in sight loss is also unwarranted. The study was to test the safety of the test, not to measure outcomes in terms of preventing blindness.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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