Importantly, it was the only story to explain that we don’t yet know whether the new drug prolongs the survival of patients with metastatic melanoma. Somewhat surprisingly given the story’s attention to these details, it failed to describe or make any attempt to quantify the potential harms of the new drug, which are not trivial. It also allowed an expert to extol the benefits of screening for skin cancer prevention when this approach is not clearly supported by the evidence.
Messages promoting cancer screening are ubiquitous but not always evidence based. As one of our reviewers completed his work, New England Patriots owner Robert Kraft is urging women not to be afraid of false-positive mammograms during the halftime of a preseason football game. Journalists need to counter this knee-jerk advocacy with sober and balanced discussion of the benefits and risks.
The story didn’t mention costs, which is somewhat understandable given the early phase of research. But the competing USA Today story, while noting that drug pricing hasn’t been set, at least noted that many new cancer therapies "cost $5,000 to $7,000 a month." This story should have done something like that as well.
The story does a good job of quantifying the benefits. It explained that 81% of patients had a partial response, meaning some shrinkage of the tumor, and gives the absolute number of people this represents. It also explains that the drug is effective in only the 50% of advanced melanoma patients with a specific genetic mutation. Although it cautions that a "sizable proportion" of patients developed resistance to the drug, we wish it had been a bit more precise in its characterization of this problem.
There was no discussion of harms in this story — somewhat shocking when you consider that safety assessment is the primary objective of phase I research. The suggestion that this drug may substantially increase the risk of another, less invasive type of skin cancer, certainly warrants some attention. The accompanying editorial in the NEJM commented: "Overall, PLX4032 had moderate toxicity, with rash of grade 2 or 3, fatigue, and arthralgia being the major dose-limiting toxic effects. Somewhat unexpectedly, cutaneous squamous cell carcinomas developed in a significant percentage of patients."
This story gave a lucid account of the research and communicated some of its key limitations. It noted that the dramatic results of this small study of very sick patients may not be generalizable to the broader population of individuals with melanoma. It also pointed out uncertainty regarding how long the drug will remain effective.
No disease-mongering here.
The story quotes a dermatologist with no links to the research. Not coincidentally, she is the only person in any of the three stories we reviewed about this study to point out the lack of conclusive data on survival. The story also notes that the trial was funded by drug maker Roche.
The story notes that only about 15% of patients respond to the standard treatments for metastatic melanoma — chemotherapy and interleukin-2. But it veers into questionable territory when it allows an expert to claim that "the best defense against melanoma is to get your skin examined regularly by a professional who knows what to look for." In fact, recent guidelines from the U.S. Preventive Services Task Force conclude that there is insufficient evidence to tell if regular screening helps prevent deaths from skin cancer. A thorough discussion of this issue would have included an opposing comment about the uncertainty of the evidence.
The story specifies that the new drug is "experimental" and in phase 1 clinical research. Readers can conclude from this that the drug is not widely available.
The story describes the research that led to the development of the new drug. By all accounts the drug does represent a novel and exciting approach to the treatment of metastatic melanoma.
We feel pretty confident that this story didn’t rely on a news release.