Notwithstanding the headline, this is a story about two drugs for the treatment of advanced prostate cancer – Provenge, a drug recently approved by the FDA for the treatment of advanced prostate cancer and XL184, a compound currently under study. Combining the information for these treatments is a bit confusing. The news about XL184 reflected results which at that point had not yet been presented at a cancer conference in Berlin. While indicating that it is too early to say whether XL184 actually affects the cancer, the story should have reminded readers of the importance of things like quality of life and survival time. And there isn’t evidence about those factors yet with XL184. At issue is that, while advanced prostate cancer is a challenge, not all men with advanced prostate cancer would benefit from Provenge, though the story neglected this. And it is not clear that XL184 is of benefit to anyone.
News about results from a small study that is still ongoing cannot carry enough caveats. It is really too early to know whether XL184 really shows promise or not. It is bad enough when journalists write glowing stories based on reports from scientific meetings. This story goes one step beyond that and reports on the outcome of a small trial before the scientific meeting has even been held. Although there are numerous caveats embedded in the story, it still provides a rather optimistic view of a drug based on early testing in 20 men. For reasons that we don’t understand, the story only reports on 20 of the 99 men enrolled in the study and only reports on the more positive results (those related to bone scans). This selective reporting provides the readers with a very limited and imbalanced view of the study results.
The story provided the costs for the FDA approved Provenge ($93,000/patient); as XL184 is under study and not available for sale, there was no information about what its costs might be.
The story included the numbers of men who were seen to have improvement in their bone scans. While reporting on the improved bone scans seen in the men treated with XL184, the story did include some balance by indicating that this scan change might not translate into a change in the cancer in the bone and that nothing was yet known about how the drug affected longer term outcomes.
The increase in median longevity observed with Provenge was reported from one study, without including the insight from the two other larger scale studies.
In a split decision, we’ll give the story the benefit of the doubt on this criterion.
There was no mention of any possible harms associated with XL184 even though information available from the company indicates that fatigue, diarrhea, nausea, high blood pressure, rash, ‘hand-foot syndrome’, and cough have been seen in the small cohort of men treated with XL 184 for 6 weeks or more.
And while indicating that Provenge helped men with advanced prostate cancer live 4 months longer, there was no mention of any harms associated with use of this drug.
This story provided no information other than positive findings of the study and the number of men treated. There was no information about the study design, length of treatment, length of follow-up or adverse events that were reported.
The story did not do an adequate job detailing the level of information coming out of the ongoing study on XL184. While reporting that 19 out of 20 patients experienced improvement in their bone scans, it only mentioned that ‘some’ patients were able to stop taking pain medications as after taking XL184. Having a better looking bone scan is really not a meaningful endpoint for patients.
Although the story indicated that the results reported on were ‘very early results’ it should have explained what was meant by this statement. XL184 is currently being studied in a shotgun trial where the investigational compound is being tried in patients with a variety (in this case 9) different solid tumors. It is a phase II trial; and it is currently underway.
The story did not engage in overt disease mongering.
The story quoted at least one clinical expert who did not appear to have ties to the study reported on or the company that makes the drug.
It would have greatly improved this story if insight from an expert on prostate cancer, especially castration-resistant prostate cancer had provided a context for evaluating the benefit of the drugs reported on – including quality of life issues.
The story did an inadequate job of explaining the target group of men who would be appropriate candidates to consider Provenge or for the study of XL184. And while mentioning that Taxotere, a drug currently used to treat advanced prostate cancer, has not been shown to have much affect on bone scans, the story could have seized the opportunity to explain that the benefits seen with Taxotere have not yet been demonstrated for XL184. The story went on to add that drugs like Zometa and denosumab, used to treat bone lesions in men with advanced prostate cancer, haven’t been shown to fight cancer itself. In fact – neither has XL184. At this point – what we know is that after 6 weeks of treatment XL184 improves the picture seen on bone scan. But we do not yet know whether it changes the course of the cancer itself – i.e. do men live longer?
The story provided clear information about the availability of Provenge and XL184.
The story was clear about the novelty of the two drugs presented.
We can’t be sure of the extent to which the story relied on a news release. We know there was independent reporting because we know that several interviews were conducted. But if the study results had yet to be presented and have not been published, where did the information come from? There was a company press release (http://www.exelixis.com/investors-media/press-releases ) and/or review of a poster before it was presented and/or there were advance interviews with researchers promoting their work.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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