This news release highlights the “miracle” response of a single patient with triple-negative breast cancer to a drug combination that included an experimental cancer vaccine and a biosimilar of the drug pembrolizumab (marketed as Keytruda).
Far from objective, the release relies on strong emotional language such as “remarkable,” “miracle” and “shocking” to make the case for the drug combo instead of solid evidence and quantified benefits. The release also makes a pitch to breast cancer patients to become hospital clients, and to pharmaceutical companies to fund future clinical trials of the drug combo.
The release is premature. It’s based on a single case. There’s been no long-term follow-up and researchers say they don’t know which element of the treatment may have benefited the patient.
We’ve profiled City of Hope’s penchant for “miracle mongering” previously on HealthNewsReview.org.
Highlighting a single person’s preliminary reaction — she had not yet even completed the treatment — to an experimental drug combination and calling it a miracle creates a false and biased narrative of the true effectiveness of this treatment.
The release noted that in previous patients with different types of cancer, no clinical benefit was seen with the drug combination and in this single case study, researchers weren’t sure what caused the patient’s improvement.
The release referred to a combination of a new vaccine targeting the p53 gene and a pembrolizumab biosimilar. Pembrolizumab is currently used as a chemotherapy drug but no mention of costs were given for this drug or the combination treatment of the vaccine with pembrolizumab. According to GoodRX, four vials of 50 mg Keytruda cost around $9,000.
It’s irresponsible to suggest a sample of one patient represents a miracle cure as this release does, particularly without providing any hard data to back up the claims. The release noted that the patient’s skin lesions had diminished and that biopsies showed no cancer, but we do not know beyond this patient what sort of benefit the drug treatment combination should yield. The release noted that in previous trials on different types of cancer, patients had an immune response but provided no details.
The release also noted that the patient had not yet undergone bone and CT scans to assess whether other sites of tumor have regressed and it states the patient was still undergoing treatment. Therefore, benefits are ambiguous at best — and should have been treated as such throughout the release.
There was no mention of side effects of the combination treatment and only a brief mention that this drug combination showed no clinical benefit in other patients.
This release is highlighting one patient’s response to the combination therapy. Only far down in the release do we learn that it’s unclear if it was the experimental vaccine or the pembrolizumab biosimilar that had reduced the patient’s skin lesions. It doesn’t warn that we don’t know how long this benefit will last or that the cancer could develop resistance to the new combination therapy. Even with this dearth of evidence of effectiveness, the release still claims the patient had a “shocking response” and refers to her as a “miracle patient.” The release is clearly lacking in evidence, and we’d suggest that the writer look at our Six tips for writing accurately about cancer immunotherapy drugs before tackling this topic again.
The release doesn’t engage in disease mongering. It focuses on late-stage cancer which for many people leaves few options for treatment. This is considered a terminal, non-curable disease. While patients are living longer with a diagnosis of metastatic disease, they are not at this point being cured of it.
It’s important to inform patients when there are newer experimental therapies and highlighting a good initial clinical response is very important. But it needs to be done in the larger context of metastatic breast cancer. This release should be called out for “miracle mongering.” Referring to someone as a “miracle patient” might convey to a lay person or average patient that the patient in the story has been cured. Cutaneous lesion regression is certainly a good sign, but systemic imaging and long-term follow-up is needed before the term “cure” can be used. In addition, the release did not discuss that there are several subtypes of triple-negative breast cancer. It might not be expected that all cases of advanced triple-negative breast cancer would respond to this therapy.
There was no mention of where the funding for the vaccine research came from, but the researcher who developed the vaccine was quoted in the release saying they were seeking funding for a larger vaccine trial. There was also mention of several drug companies expressing interest in the vaccine, but it’s unclear if any of those same companies have given any money for testing.
The only alternative mentioned in this release was hospice. Because this type of cancer is considered a terminal, non-curable disease if the patient has not responded to surgery, radiation and standard chemotherapy, that may be appropriate. However, the vaccine described here isn’t the only experimental treatment in development. There have been mixed results in studies of iniparib combined with chemotherapy, and immunotherapy. Some other experimental treatments could have been mentioned, along with palliative care.
While part of the drug combination (pembrolizumab) mentioned in the release is available, the experimental p53 vaccine appears to only be available through a City of Hope researcher. There was mention of a desire to create clinical trials open to “to women from all over the country” but that’s far from certain.
It’s clear from the release that City of Hope is trying to recruit new patients and generate pharmaceutical sponsors. Many patients with this type of breast cancer may get the impression from the release that they, too, can receive this “remarkable” treatment if they make their way to the hospital. But how practical is their open invitation? Experimental therapies like the vaccine are not covered by health insurance.
The release notes the p53 vaccine has been used in clinical trials since 2010. The release isn’t claiming that the vaccine is brand new and has never been studied before. The new information reported in the release is that one patient apparently responded favorably to the treatment, at least in the short-term.
Liberal use of words and phrases like “potentially revolutionary,” “miracle,” “pretty unprecedented” and “shocking” to describe the treatment response are all unjustifiable and misleading. The results are only for one patient — who had not yet completed the full treatment at the time this release was issued — and there’s been only very short term clinical followup.
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
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