As the nation’s largest cancer center, MD Anderson made a splash in 2012 with its ambitious announcement of a multi-billion dollar Moon Shots Program, which it called an unprecedented effort to rapidly convert scientific discoveries into life-saving advances. This news release, about a phase II clinical trial of the immunotherapy drug nivolumab (marketed as Opdivo) for one type of anal cancer, is decidedly more down to earth. The news release refrains from hype but still falls short of the mark when it comes to describing costs, potential harms, and comparisons with existing treatments. While calling results “encouraging,” the news release would be more helpful if it provided a meaningful assessment of whether this therapy might advance the Moon Shot’s directive of saving lives.
Anal cancer is relatively rare. The American Cancer Society projects 8,080 new cases and 1,080 deaths in 2016. The number of new anal cancer cases has been rising. It is found mainly in older adults, with an average age in the early 60s. The risk of being diagnosed with anal cancer during one’s lifetime is about 1 in 500, with women at slightly higher risk. Squamous cell carcinoma of the anal canal (SCCA) is the most common form of anal cancer and is linked to infection by the human papilloma virus (HPV), the same virus that causes cervical cancer. The chemotherapy and radiation protocols that have been used to treat anal cancer have remained little changed since the 1970s, and there is no FDA-approved chemotherapy drug specific to anal cancer, according to the HPV and Anal Cancer Foundation. In recent years, a new class of drugs called immunotherapy drugs that unleash the body’s own immune system to attack cancer have offered a potential alternative to traditional treatments for several types of cancer.
There is no discussion of the sky-high cost of nivolumab, the drug tested in this study. It’s disappointing because it’s at least the second time MD Anderson has failed to mention the cost of this drug in a news release. In a separate review last fall, HealthNewsReview.org calculated the monthly cost of nivolumab to be in the vicinity of $12,600, excluding administration. Nor does this review address whether a patient’s health insurance is likely to cover the cost.
The patients’ response was modest and the news release reflects that. The release quotes a researcher saying, “This study demonstrated responses in five of 18 patients treated at MD Anderson, and many of the patients had significant reductions in their tumor size.” It also gives details of some of those treatment responses.
This news release makes no mention of potential harms. According to the Chemocare.com website, more than 30 percent of patients on nivolumab may experience fatigue, low white blood cells, low sodium, shortness of breath, musculoskeletal pain, decreased appetite and cough.
The news release falls short here because it fails to explain how a reduction in tumor size or other responses to treatment might translate into what matters to patients: quality of life and survival rates. The news release does note that “final clinical results” will be reported at the American Society of Clinical Oncology’s 2016 annual meeting in Chicago, but would have been more helpful if it mentioned when that will occur and what additional data will be released.
No disease mongering here. In fact, the news release mentions right off the bat that this form of cancer is “rare.” The news release also highlights the fact that squamous cell cancer (SCCA) is “on the increase,” but it would have been helpful to provide details that might help readers understand why cases are increasing and at what rate.
The news release could have been transparent about financial backing. Funding sources are listed, but there is no mention of whether individual researchers have potential conflicts of interest. In our review of MD Anderson’s kidney cancer news release last fall, we noted that one of the researchers involved in that study is a paid consultant to the maker of nivolumab, Bristol-Myers Squibb. That researcher, Padmanee Sharma, M.D., is also part of the anal cancer study team. Neither news release noted her financial tie, and the reader is left to wonder whether any of the researchers have vested interests in the study outcome.
Immunotherapy may offer a less toxic alternative to traditional chemotherapy, but there is no mention of that here. In fact, there is no attempt to describe the relative advantages and disadvantages of nivolmab versus the traditional treatment protocol. The release also neglects to mention that human papillomavirus (HPV) vaccine has been proven to prevent anal precancerous lesions and has the potential to make this tumor even more rare.
The news release squeaks through here, describing nivolumab as “one of the drugs represented among the growing arsenal of immnotherapy therapies.” This might imply to the reader that the drug is already available to treat other conditions. However, it does not state specifically whether the drug has FDA approval for anal cancer or any other application.
There is no question of the newness of immunotherapy drugs for treating cancer. The news release heralds this as the “first-ever” study of nivolumab on aggressive anal cancer. Still, the news release could clarify whether this is the first trial of any immunotherapy drug for anal cancer and if so how this study contributes to body of evidence of the potential for immunotherapy drugs to improve treatment options for patients.
No outright sensational language, but the news release failed to explain its use of the word “encouraging” to describe study findings. There is no quote from a researcher to back up that adjective. The study abstract only mentions “potential correlations” between immunological biomarkers and clinical outcomes to nivolumab.
Systematic, Criteria-Driven
The tsunami of news and information around potential COVID-19 vaccines is relentless. When communicating about this topic, choose your words carefully and focus on the data, says @garyschwitzer.
#scicomm #journalism #media
https://review.content-science.com/covering-covid-19-vaccine-news-part-two-from-the-publisher-of-health-news-review/
I find the work of @HealthNewsRevu amazing for Health journalists and people dealing with Health information, please look at their toolkits if you don't know them
https://www.healthnewsreview.org/toolkit/
A week like this should teach you how/what to ignore: #COVID19 news & PR about studies in monkeys & mice...about studies of dishonesty & BMI…and about rating attractiveness of women with endometriosis!!! https://www.healthnewsreview.org/2020/08/crazy-week-of-pr-news-on-studies-should-teach-us-how-what-to-ignore/
Comments (1)
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Susan Briggs
April 28, 2016 at 4:29 pmBeing an anal cancer survivor who had the standard chemo/ radiation protocol, which proved to eradicate my SCCA but leave me with pelvic radiation disease, I question several things in this report. First, the suggestion that most anal cancer patients are in their 60’s is incorrect. Most of us are in our early 50’s and many of us are in our 40’s. Secondly, this article fails to mention what happens if immunotherapy with this drug fails. Is there then the option for chemo/radiation therapy or is the patients only option a colostomy? The real downfall of what is presented is that the side effects are not clearly stated, addressed or have treatments. This is just as damaging as the side effects from chemo/radiation, for which there is no studies, treatments or cure. In fact for the most part the US medical doctors walk away from the patient once treatment is complete, totally ignoring pelvic radiation disease as anything they can manage. Let’s solve the side effect issue before “trying” something that may or may not work. Chem/radiation at least is proven to be 85-95% effective.
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