Cancer immunotherapy drugs are big business, and many news sites feverishly report whatever drug companies send out about the latest clinical trials–even before the data can be verified by outside parties. Such is the case with this story from Reuters, which reports on a phase 3 trial for Keytruda, an immunotherapy drug.
We liked that the story included absolute numbers on the performance of the drug–readers can read between the lines and see that survival improved by just three months. Yet the story skirted over some key details, notably how expensive this drug is.
Reuters’ main audience may be investors, but this story will undoubtedly find its way to patients and loved ones. Some details that they care about–such as the incredibly steep price tag and potential for adverse effects–ideally would have been covered more thoroughly.
The cost of the drug is not discussed, and this is a significant oversight. As we’ve noted in another review of a story on Keytruda, “the cost is about $150,000 a year.”
Insurance coverage and high out-of-pocket costs are another issue that could have been addressed.
The story does quantify the benefits of the intervention, and it does so in absolute terms.
“Merck said data from an open-label Phase 3 trial of 542 advanced bladder cancer patients showed median survival of 10.3 months for Keytruda patients and 7.4 months for patients given second-line chemotherapy. The study’s median follow-up was 18.5 months. After 18 months, 36 percent of Keytruda patients were alive, compared with 20.5 percent of chemotherapy patients, according to research published by ASCO. The study did not detect a difference in the length of time patients lived without their disease getting worse.”
This is sufficient to be satisfactory, but we do think more could be said about if this minimal time difference truly make an impact on patients’ lives, or not. Are the patients healthy enough to make meaningful use of the additional time they receive with treatment?
The story only tells us that:
Severe side effects were reported in 16.5 percent of the Keytruda patients, compared with nearly half of the chemotherapy group.
But what does severe mean? And how often did less severe side effects occur when patients were on Keytruda?
As we’ve discussed in 6 tips for writing about immunotherapy, there’s a tendency to underplay the harms of immunotherapy drugs.
The story tells us this was an open-label phase 3 trial, with 542 patients. Lay readers (including bladder cancer patients) who come across this story may not know what either “open-label” or “phase 3 trial” means, so the story could have done more to explain.
But more importantly, the story should have explained that since this data is unpublished and not available for review by anyone, we have no way of knowing if what the drug company says is accurate. Nor can we see limitations to the trial, like a high drop-out rate.
Another thing that experts might look at is how many chemotherapy cycles each patient was able to receive, which would be critical to understanding how well the drug was tolerated.
This is a barely passing satisfactory. Some numbers on how common advanced bladder cancer is, and its mortality rate for standard treatment, would have been useful.
The story has no sources. It needed an independent voice to provide comment on what it means to see survival increase by only a handful of months, particularly for such an expensive treatment. Is the trade-off worth it? Will doctors readily prescribe this treatment?
The story mentions that this drug was compared against standard chemotherapy.
The story makes it clear that the drug is not currently approved for this type of cancer, but is approved for other types.
The implied novelty here is that this drug seemed to have demonstrated effectiveness in phase 3 trials, unlike a similar competitor’s drug, which had lackluster phase 3 results for the same purpose.
The story includes original background information on similar drugs from other competitors.
Systematic, Criteria-Driven
@HealthNewsRevu "There’s no harm in trying to make a buck, per se. But there is harm in promoting things that are not backed up by evidence, and in converting normal states of health into sickness" https://t.co/aeUTK4CVAs
Men’s Health Month: "Some of it was thinly-veiled, profit-driven fear-mongering," says @garyschwitzer: https://t.co/MOWdxlenvz
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