The federal Food and Drug Administration has just approved a modified herpes simplex virus as a treatment for advanced-stage melanoma. The virus, which is designed to activate patients’ own immune systems, has been shown to shrink tumors for at least six months in patients who have run out of treatment options. This story does a nice job of explaining the way the virus works and offers readers reactions from a variety of scientists. Clearly a lot of legwork went into this story. But we were disappointed to see that none of these sources provided any critical evaluation of the research or pointed to any caveats — of which there are quite a few. In addition, while the piece’s patient stories don’t overdo the “good news” aspect of the treatment, we wished for more data and a more thorough discussion of the ultimate outcomes that matter to patients such as survival time.
Newer and experimental treatments for malignant melanoma have changed the uniformly poor outcome for this cancer. But the legitimate excitement surrounding these treatments must be tempered with acknowledgment that the benefits are limited and not everyone benefits. The treatments are very costly and can still cause significant harm to patients.
The story nods to costs when it says the company will charge the patient $65,000 for a treatment. But they actually will be trying to charge insurance companies this amount. How widely will it be covered and when? How many courses of treatment will be necessary? We’ll give the benefit of the doubt here but the story could have done more to clarify.
The story indicates that the treatment caused some tumors to shrink for at least 6 months, particularly in those whose cancer had not yet spread to internal organs. But the overall discussion of benefits is lacking some important details. What does “shrink” mean? And when it says that 16% “responded,” what exactly does that mean? (Of course, 84% did not respond — a statistic that was also worthy of comment in our view.) Finally, important outcomes, such as length of survival, are not presented or compared with alternatives. One study reported that median survival was 23.3 months with the new drug vs. 18.9 months with the comparison treatment — a finding that would have been easy to include. The FDA cautioned in a news release that “Imlygic has not been shown to improve overall survival.”
This is a close call, but we think the story downplays the significance of the harms attributable to these drugs. The story quotes a researcher who calls one drug “low-toxicity” and lists 3 adverse effects, but does not say with what frequency they occurred. According to the linked study, 11% of patients developed grade 3 (severe) and 4 (life-threatening) adverse events related to the treatment. We don’t think that’s what readers have in mind when they hear “low-toxicity.”
No real study results are provided for us to assess. We aren’t told how the 436 patients mentioned in one study were selected, what the comparison treatment was, if there was a random assignment, and so on. The study itself mentions an open label design (both researchers and patients knew who was getting what treatment) that “may have influenced assessment of some end points.” We wish the story had delved a bit deeper into the research and discussed the potential limitations.
Metastatic melanoma is a serious disease that is difficult to treat successfully. The story heralds this use of a genetically modified herpes simplex virus as important, and we think that is an appropriate judgment.
The story quotes a number of experts and clearly a lot of legwork went into the reporting. But two of the sources quoted in the story consult for Amgen, the company that will sell this treatment, and they are not so identified. From the description provided in the story, some readers can probably gather that these experts are involved with the company. But it would have been better to state clearly that these are paid consultants. In addition, we wish that any of the sources quoted in the story had raised questions, pointed to limitations, or provided some critical analysis of the research. The overall tone of the piece is optimistic and positive — overly so in our view.
The story mentions another drug called Yervoy and also mentions conventional treatments. It also describes other virus-based treatments that are under development.
The story notes that the drug has been approved by the FDA, so we’ll award a Satisfactory grade here. But the story could have gone further. Folks with advanced-stage melanoma do not have anywhere to turn; they will be keen to follow up on this information. A news release from Amgen indicated that the company would make the treatment available within a week, so more thorough availability information appears to have been, well, available.
One of the main points of the story is that this is the first virus to be approved by the FDA for advanced-stage melanoma. That’s about as novel as you can get!
Amgen issued a news release on the same day as the Boston Globe/Stat story was published; there is enough original reporting that we can be sure the story went beyond this or any other news release.