This story about an experimental hepatitis C treatment known as BMS-790052 wants to have it both ways. It leads off by telling us the drug is in very early clinical testing; we don’t know if the drug works; and that it will be years before it could ever be dispensed to patients. But then it proceeds to speculate irresponsibly about how the drug could be used with two other experimental drugs to potentially "cure" many people with hepatitis-C and encourage others to get tested. Also troubling is a prediction that these other experimental drugs will get approved by 2011 and become a "standard treatment" for many people with hepatitis C. This crystal ball-gazing comes courtesy of a researcher who has financial ties, not disclosed in the story, with all three drug manufacturers who are developing the new treatments discussed in the article.
Since BMS-790052 is still in early testing, we don’t know what it will cost, so the criterion is not applicable. However, given the huge costs of the existing treatment regimen of an interferon and ribavirin, a comment on the potential economic impact of a third drug would have been helpful. Current treatments cost several thousand dollars per month with treatments lasting for 6-12 months. The addition of a third and presumably expensive antiviral is an important aspect of the costs of treatment.
According to the story, patients who received BMS-790052 had lower levels of the hepatitis-C virus in their bodies for several days. While this is an appropriately sober description of an early phase clinical test, the discussion of the other two experimental drugs mentioned in the article was, as discussed above, not nearly as judicious. Saying these unapproved drugs will "boost cure rates," without delving into any of the evidence which supports the claim, strikes us as hype rather than help.
The story mentions that the main side effect of BMS-790052 in early testing was headache. But considering that this was a phase 1 study designed primarily to collect information about drug safety, we think it’s unfortunate that the story chose to emphasize a secondary test result –reduction in viral load — and downplay potential safety issues.
There is also no discussion of the potential harms associated with the other experimental drugs that the story suggested would help treat hepatitis C. If a story is going to pass long claims that unapproved drugs are going to cure hepatitis C, we feel it also needs to provide the full picture of the harms these treatments may entail.
The story emphasized the early nature of the research on BMS-790052 and included important caveats about the small size of the study and the lack of data showing effectiveness. The story probably should have been more explicit in stating that these short-term results do not automatically suggest that the benefits will endure over the long-term.
The story showed distressingly little restraint when discussing two other investigational drugs which are in late-stage clinical testing. It said these drugs would become a "standard treatment" for hepatitis C and would "boost cure rates into the range of 70 to 80 percent." But the only support offered for these statements is the word of a University of Miami researcher who consults for the companies developing the drugs. Such bold predictions need to be backed up by a discussion of the clinical evidence.
This story leans heavily on the comments of Dr. Eugene Schiff, who is identified only as the director of the University of Miami’s Center for Liver Diseases. However, as a recent disclosure statement from a continuing medical education program in which he participated shows, Dr. Schiff is a consultant to Bristol Myers Squibb, which is developing BMS-790052, as well as Vertex and Schering Plough, which are developing the other two experimental drugs mentioned in the article. We feel these relationships should have been disclosed to readers.
The story gives an inaccurate portrait of how the treatment approach with the new antiviral drugs will differ from the current standard regimen. The story suggests that the new drugs will replace existing treatments, but studies of newer antivirals have used the drugs in combination with standard therapy not in replacement of it. The story should have clarified that the newer agents will, at least initially, be used as an adjunct to existing therapies if and when they receive FDA approval.
Although the story points out that BMS-790052 is in an early phase testing and nowhere near being available to patients, it improperly relayed the prediction of a researcher who said that two other investigational drugs were expected to become available by 2011. The prediction is especially troubling given the undisclosed financial ties between the researcher and the manufacturers of the investigational agents (see source/conflict of interest criterion below).
The story notes that there are other drugs like BMS-790052 currently in development for hepatitis C.
We can’t be sure to what extent this story relied on a news release, so we’ll call it not applicable.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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