Key details are provided by the Times that were not provided by a competing Reuters story, making the promise of this new asthma drug seem a little more distant. We wish that cost information, risk of harm information, and a better comparison to alternative therapies also had been provided.
The vast majority of people with asthma can control their symptoms with a combination of inhaled corticosteroids and long acting beta agonist drugs. Unfortunately, there is a small population of people whose asthma proves to be more resistant. Drugs targeting specific proteins that are involved in inflammation, such as the interleukins are under development in many companies. While there have been positive signs, not all drugs that have shown promise in early stage testing have proven to be useful in later stages of development. The early results with dupilmumab are encouraging but the road to FDA approval is not easy or straightforward. Reports of early stage studies in small and very select groups of subjects need to be viewed cautiously.
The story fails to discuss costs. Given that this drug is apparently meant to be taken in addition to other drugs, it likely will result in an increased cost to patients who already are on medication.
The commercially available humanized monoclonal antibodies used to treat other diseases like rheumatoid arthritis can cost thousands of dollars per month and are frequently singled out by insurance companies for large copays.
This is important context that was left out.
Like a story in Reuters on the same study, this story uses the same dramatic relative reduction figure, but, unlike the Reuters story, it also provides the hard numbers. It says, “During the entire 12 weeks, three of the patients taking dupilumab experienced a worsening of asthma compared with 23 on the placebo, a relative reduction of 87 percent.” It also disclosed that there were 104 patients in the study.
There is no discussion of even potential harms in the story. Even the accompanying editorial raised one issue: “Given the appearance
of increased eosinophilia in four patients in the dupilumab group, more safety data are also required.”
This story provides almost all the necessary information for readers to understand the promising aspects of the study and also its limitations. It says right in the lead, for example, that it was a “small clinical trial” and in the second paragraph says that it ran for 12 weeks.
We would have liked to have seen additional comments about the sample. Only about 1 in 10 subjects screened met the eligibility criteria for the study. Extrapolating the results to a larger and more diverse population is a bit hazardous. The accompanying editorial in the New England Journal of Medicine addressed this issue:
“As compelling as these data seem, upon closer
examination, this proof-of-principle study shows
efficacy only in a limited subpopulation of patients
with asthma. Only 21% of those screened
for the study met the inclusion criteria, probably
because of the requirement for persistent symptoms
and eosinophilia in the presence of treatment
with inhaled glucocorticoids. We do not
know whether dupilumab will be effective in
other patient populations, such as the much
larger population of patients who use inhaled
glucocorticoids and LABAs and do not have eosinophilia.”
The story does not engage in disease mongering. Instead, it provides a nice description of asthma and the subset of asthma patients who are the target of this drug.
The story did not cast a very wide net for sourcing, relying entirely on the contents of the New England Journal of Medicine paper and an accompanying editorial. But we give the story points for at least presenting a diversity of views. For one, both the Times story and a competing Reuters story referred to the editorial, but only the Times story used the editorial to note the study’s limitations and failure to prove the drug’s efficacy.
“In the commentary, Dr. Michael E. Wechsler of National Jewish Health in Denver, said that in actual medical practice, patients would not be taken off their existing medications. The real need, he wrote, is for drugs to help control asthma when used in addition to the existing medications, and the study had not demonstrated that dupilumab could fulfill that role.”
The Times also did something that Reuters did not do. It pointed out that the lead author on the story – quoted liberally by Reuters by not quoted here – “has been a consultant to Regeneron.”
The story does not provide a clear comparison between this drug and existing therapies. Olamizumab (Xolair), for example, has been available for a number of years to treat severe allergy and asthma. The story does note, helpfully, that the “In the first few weeks of the trial, when patients were still taking their existing drugs, there was no significant difference in the number of worsenings of asthma between dupilumab and the placebo”.
In the fifth paragraph, the story says, “Still, much larger studies, taking at least two or three years, are likely to be needed before the drug could reach the market.”
The relative novelty of this drug, and of the findings, are appropriately described in the story.
The story does not rely on a press release.