This story reports on the results of multiple clincial trials suggesting that the protease inhibitors, boceprevir and telaprevir, further reduce viral loads in chronic hepatitis C patients when added to standard therapy. However, this piece does not tell the reader much about the study methods, nor do we know much about the study populations. In addition to providing more information about the trials and their participants, the story should have also included cost estimates for the new drugs and for the standard therapy, pointed out the potential conflicts of interest, and presented the results in absolute terms.
As the story states, hepatitis C affects several million worldwide and while the current mainstays of therapy (peginterferon and ribavirin) were major advances in treatment, a significant number of people do not respond to treatment with these drugs and are at risk of developing cirrhosis or liver failure.
The story merely quoted one hepatitis C specialist saying, “This is a very expensive drug, and I would imagine some insurance companies would not pay for it.” But why not give specific cost estimates? Even a framework for what “very expensive” means.
As we wrote on our blog (a piece that commented on how inconsistently some journalists deal with drug cost information), “It’s probably safe to say that the cost will be in the thousands per month. The costs of existing treatment is about $70,000 for 48 weeks of treatment.”
You better believe that any company that expects drug approval within a month knows what its pricing will be.
Also, the story could have mentioned the specific cost of erythropoietin, since the trials found that many participants require it to combat the anemia that often results from the treatment.
The piece presents the results in percentages; however, it would have been more meaningful to the reader if the story had also provided the actual numbers, particularly since it did not mention how many people were in each of the treatment arms. In addition, one of the trials evaluated the efficacy of boceprevir in a black cohort—a population group that usually does not respond as well to treatment—but these results were not discussed in the story. Furthermore, the story does not provide any data for telaprevir, but only states that “outcomes were similar” to boceprevir.
The study points out that a major side effect of the new drugs is anemia, and more than 40% of patients in the boceprevir studies required erythropoietin to combat it; however, the story should have noted that over 20% of patients in the control groups also became anemic. In addition, there was a high drop-out rate in the two trials, which should have been mentioned. Why did so many drop out?
The story uses the term “phase III trial” throughout, but do we expect readers to know what that means? The story should have also provided more information about the patient population, including age, race, and number of participants in each arm. In addition, the story gives very little information on the telaprevir trial.
This story does not engage in disease-mongering, but it would have been helpful had it indicated what percentage of the 3.2 million Americans living with chronic hepatitis C have the genotype 1 infection, for which these new drugs are indicated.
While the story uses independent sources, it fails to note that Merck, the maker of boceprevir, sponsored the two clinical trials published in the New England Journal of Medicine. It also fails to mention that many of the study authors have received funding from Merck.
The story compares the new drugs to the standard therapy for chronic hepatitis C.
This story makes it clear that boceprevir and telaprevir are not yet available, but they may be reviewed by the FDA at the end of April.
It’s clear from the story that triple-therapy is a new treatment approach for chronic hepatitis C.
The story does not appear to be based on the press release.