More miracle-mongering in City of Hope news release about breast cancer vaccine

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

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.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

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.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

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.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

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.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

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.