We applaud this story for taking the time to walk readers through the different side effects from the drug — including patient deaths — and for raising the issue of the high cost of the drug. However, we would have liked to have seen a clearer description on the benefits of the therapy and more explanation of both the evidence underpinning the findings and the availability of the drug.
Though the tone of this story is that CAR T-cell therapy represents a cure (“This is not just an incremental benefit”), the results suggest otherwise. The story states that at 6 months only 44% are still responding and 39% have no sign of cancer. There was no control group, and it’s still early on, so whether this therapy represents a long-term cure and for how many remains to be established.
For patients with aggressive non-Hodgkin’s lymphomas who have failed conventional treatment, and face an otherwise bleak prognosis, CAR T-cell therapy offers a new option. But given the very high cost of this treatment, the limitations of the research and the lack of long-term information on survival, readers need to understand that it’s not clear yet just how great this new option is.
The story states the cost of this new therapy. It also contrasts it to the other approved drug for CAR T-cell therapy. However, it would have been helpful to know if this cost includes all the related hospital care and services, or is simply the cost of the drug itself. It also would have been useful to compare it to other treatments for this form of cancer, such as chemotherapy or transplantation.
The story describes the scope of the benefits for the patients this way:
“An independent review committee found that 72 percent of patients treated with a single infusion responded to therapy, including 51 percent who then showed no evidence of remaining cancer. Kite has said that at six months, 44 percent of patients were still responding, with 39 percent having no sign of cancer.”
While the story is murky on the details, this is in reference to 101 patients who received the therapy. This survival outcome was compared to historical data related to how long most people survive if they have no response to first-line treatments. This comparison is not the same as having an actual control group, and the story should have been clearer about that and what it means.
The story wisely documents the harms found in the trials for the drug, including patient deaths. This is important, and helps balance the glowing patient anecdote from a woman whose cancer went into remission.
The story is not as clear as it could be on the quality of the evidence. It’s unclear, for example, whether any of the findings have undergone any sort of peer review or have been published. And, what are the limitations of FDA fast-tracking a “breakthrough” therapy? Probably the most important detail to explore, as mentioned earlier, is that there was no control group.
The story does not engage in disease mongering, and did a nice job discussing the prevalence of this type of cancer.
There are no independent sources in this story. It would have benefited greatly from at least one outside voice commenting on the importance of the findings.
The story discusses other drugs on the market. The implication is that the patient has failed all other available treatments. For insurers this will be a major point. Given the cost of the treatment, insurers may require additional standard therapies that may be less effective but significantly less costly. Moreover, how this new therapy compares to others has not been directly tested. It doesn’t appear that any such head to head comparisons are in the near-term future.
The piece isn’t clear on this point. It says “[T]he agency [FDA] is requiring hospitals and clinics that dispense Yescarta to be certified after undergoing special training.” This implies that not all places will be able to prescribe this.
The story explains that this is a new therapy and is the second approved treatment of its kind.
Many of the facts and some of the quotes in the story come from the news release put out by the FDA, but there were enough unique details to give the story a pass in this category.
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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