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
Puleeeeease... this 'game changer' weight loss drug causes more nausea and vomiting than a placebo. Some game, some change. My friend Gary would spank you for using the eighth word medical reporters should never, ever use. @garyschwitzer @thackerpd
https://www.healthnewsreview.org/toolkit/just-journalists-writing-tips-case-studies/7-words-and-more-you-shouldnt-use-in-medical-news/ https://twitter.com/OttawaCitizen/status/1361426796126830597
A scary @statnews Op-Ed warns that govt attempts to rein in Pharma may cut off access to "life-changing" drugs.
It takes @garyschwitzer to let us know: the author spent 10 years as Pfizer's public-policy chief. https://twitter.com/garyschwitzer/status/1360325022578053123
.@TranspariMED criticizes STAT op-ed for not disclosing pharma funding of author’s institute - similar to criticism we’ve made of STAT op-eds in the past. @transparify @ThinkTankWatch @icer_review https://www.healthnewsreview.org/2021/02/transparency-watchdog-criticizes-stats-non-disclosure-on-pro-pharma-op-ed/
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like