This news article describes a small clinical trial of an enzyme engineered to remove sensitizing antibodies from a patient about to undergo kidney transplantation within a few hours, increasing the chances of transplant success for potentially thousands of patients whose bodies are likely to quickly and forcefully reject a donor organ and for whom it is highly difficult to find a compatible tissue-matched donor. So-called pre-transplant “desensitization” is a strategy that has been around for about 15 years, but the new study involves a one-time, shorter-term, less complex approach than previous efforts.
The article includes most of the needed cautions, shortcomings and barriers to clinical use of what remains an experimental treatment. However, the piece needed a stronger, explicit statement up high in the story that this treatment is clearly not yet ready for prime time, especially to counter the headline, which needed more context.
Any strategy that can safely, effectively, more easily and at lower cost improve successful transplant rates will be newsworthy to thousands seeking donor organs. But these hopeful patients also deserve to know the hurdles that stand in the way before the treatment is available to them. This story covered most of those hurdles.
Although the article notes that current desensitization efforts involving time-consuming immune system drug infusions to stifle rejection antibodies add up to $30,000 to the cost of a transplant, it does not make any estimate of the cost of the enzyme infusion that was the subject of the “novel” approach described in the new study. Based on later comments, it is presumed to cost about $65,000.
The story does an adequate job of noting the actual numbers of patients in the study group, the absolute number that were able to have a successful transplant and the absolute number who later had a rejection episode that required standard anti-rejection therapy.
Although the article makes clear the patients were “successfully treated” if sensitizing antibodies returned, it does not give any information about side effects, from the enzyme infusion nor the anti-rejection drugs subsequently used.
To its credit, the article does emphasize that the long-term value of the new therapy is open to question and that far more work needs to be done to answer questions about quality, safety, efficacy and cost.
The article tells us little about the people who participated in the clinical trial, such as type and duration of previous disease treatment, age, gender, race, co-morbidities, insurance status and so on. Nor will the reader get a really clear idea of how healthy–or ill–patients have done on other desensitization protocols overall and in the long term.
No mongering here.
The article duly discloses that the study was conducted or somehow supported by Hansa Medical, the maker of the enzyme infusion, and quotes at least two experts not involved in the study itself.
The story mentions the existence of other desensitization efforts. But it could have done a much better job of comparing such efforts and their likely impact to programs designed to increase the supply of tissue matched organs and to suppress rejection of donor organs.
The article makes clear that the only way for patients to receive the experimental therapy at present is through a clinical trial, although it does not say where such trials are taking place or recruiting patients.
The article makes it clear that this treatment is novel, but could have been much strengthened if it had explained more of the biology of the enzyme and the way it was developed. One of the experts quoted was clearly astonished enough at the effects of the enzyme that he would consider it a “game changer” if further studies verify its impact. But just why the enzyme works is not clearly explained.
Hansa Medical issued a news release pursuant to publication of the study results in the New England Journal of Medicine, but the story clearly goes beyond the release.