Is the ScoliScore genetic test of scoliosis progression risk a “tremendous advance forward,” as the company researcher quoted in this story claims, or is it “investigational” and in need of further study, as some major insurance companies have determined? Readers of this story get only the company line and none of the independent evaluation.They aren’t told about the test’s $3000 price tag. They aren’t told that the test has not been evaluated by the FDA or any other regulatory body. They are given the impression that it may be useful for a larger number of people than even the test’s maker recommends. They see the test portrayed as superior to alternatives when no such comparisons have been performed. They aren’t told that the spine specialist quoted in the story has disclosed elsewhere that he owns stock in the company. They are treated to a glowing report from a single patient (who has also been the only patient featured in other stories.)
Scoliosis is common in adolescents, but for most it is mild and does not worsen as they grow. For some, the amount of curvature is greater and the question of whether it is going to worsen or not over time becomes clinically relevant. This is the population in which this test could be considered. The question is whether this test can improve the predictive ability of the doctor in a way that improves the process and outcomes of care compared to usual practice. One issue is whether this test may identify individuals at low risk for progression who may not need to be followed as closely and may not need a brace. The outcomes are the number of xrays, visits and braces avoided and the improved quality of life that results compared to usual care. The bigger issue is a very small percent of individuals with scoliosis go on to requiring surgery. Though not addressed, a test that could identify individuals early for intervention and prevent that would be a real step forward and one that could justify the cost of this test. However, no evidence is presented that the test could do this.
According to the Axial Biotech web site, the ScoliScore list price is almost $3,000. Why weren’t readers given this information? The omission of cost is particularly troubling for two reasons. One, because the ScoliScore is new, has yet to be extensively studied by independent experts, and has not been submitted for FDA approval, some major insurance companies define the test as investigational, which means it may not be covered (depending on specific health plan contract language). Two, claims that this test can help people avoid other tests (and their costs) is a primary selling point for the company, so the cost tradeoffs should have been examined.
ScoliScore Site Training document, p. 31
Blue Cross Blue Shield of Delaware medical policy reference manual statement:
The story includes a quote calling the ScoliScore “a tremendous advance forward.” Certainly, reducing the number of X-ray exams given to young patients at risk of progressive scoliosis would be a welcome benefit; but this story makes it appear that this genetic test is better than current monitoring techniques, when that key questions has yet to be put to the test. The story offers a single anecdote of a girl who, according to her mother, was spared from being put into a back brace because of this new test. Not only does the story fail to offer any examples of other patient experiences, it’s not really clear that the ScoliScore really made the difference for this girl, since her doctor says information from the new test is correlated with results of X-ray images of the spine and other examinations.
The story does not address potential harms. What if it turns out that the way the test is applied in regular clinical practice is not as effective as conventional monitoring (either because of shortcomings of the test itself or mistakes in how it is used)? Could some young patients be deprived of effective interventions? That question wasn’t addressed by the study cited in this story, but readers should have been alerted to all the unknowns that remain to be investigated. Oh and since a simple saliva test seems so easy and innocuous, what is the risk that clinicians will overprescribe it, thus perhaps burdening families with the $3000 cost without justification?
The story should have also pointed out that this test has not been evaluated or approved by the FDA or other regulatory or professional bodies. Current law does not require this sort of test to undergo FDA evaluation.
The story cites a single study conducted by the company that markets ScoliScore. Aside from minor mistakes in describing the study (for example, reporting that it included only girls when actually it involved boys, too), the story fails to make clear to readers that this study merely compared genetic test results to clinical examinations; in other words, it looked at which combinations of genetic variations were most common among teens who progressed to severe scoliosis. The problem is that the story then leaps to the conclusion that for appropriate patients, this test is better than current monitoring methods and that it offers better health outcomes. Neither of those vital endpoints was tested in this study.
Although the story reports that “the test isn’t for everyone” and that because it is a test for gene combinations that vary with race the data so far apply only to whites, the story leaves out other important limitations, so readers are likely to believe the test could be useful for many more people than the manufacturer actually recommends. Scoliosis takes several forms (congenital, juvenile, adolescent or adult-onset) and it may also be caused by other conditions, including injuries and diseases, but the company that sells the ScoliScore recommends it only for children ages 9 to 13 who have been newly diagnosed with mild scoliosis that is not explained by some other condition. Readers of this story are likely to overestimate the number of people who might be candidates.
Although the story notes that the researcher quoted works for the company marketing the ScoliScore, it doesn’t tell readers that the clinical physician quoted in the story was also involved in the research now being used to promote the use of the test and has reported that he owns stock in the company. This doctor and the patient profiled in the story have both appeared in other stories about the test, raising the likelihood that they were both provided by the company. There are many independent experts familiar with the ScoliScore, including those who wrote the insurance company evaluations mentioned above. The story should have included some truly independent voices.
Disclosure statement published in The Spine Journal
The story makes unfair comparisons between alternatives for evaluating scoliosis. It reports positive attributes of the ScoliScore test, but only shortcomings of alternatives. The story also fails to make clear that the study cited did not compare the new test to conventional alternatives.
The story reports that the ScoliScore test is available at about 400 centers that specialize in spine and scoliosis care.
The story reports that the ScoliScore has been available since 2009.
Not applicable because we can’t be sure of the extent to which the story may have relied on a news release. However, it appears that both the spine specialist and the patient profiled in the story may have been provided by the company. If so, the story should have made any relationship clear to readers.