This story, about results from a Phase II trial of Merck’s new osteoporosis drug odanacatib, should not have been published in a mainstream publication.
Phase II results are not necessarily predictive of Phase III results or of FDA approval. Readers looking for new treatments for osteoporosis are likely to assume incorrectly that safety, efficacy and availability are assured.
The reporter could have tempered the story by interviewing independent experts with no stake in the drug being studied, who likely would have pointed this out.
Further, by talking to an independent clinician, the reporter could have learned about existing treatments for osteoporosis and how this one could–possibly, and at some point in the future–compare. Supplements, diet and exercise have been shown to slow or even halt osteoporosis for some patients. So have some drugs currently on the market.
The story also fails to clarify a point that would be valuable to consumers: That risk of fracture, not bone mass density, is the most meaningful outcome for osteoporosis drugs. Because this trial did not look at that outcome, the drug’s practical clinical value remains untested. The report should have plainly stated this caveat.
And finally, it is well known that osteoporosis is a "big market opportunity" in the pharma trade. In other words, new drugs in this field, if well-publicized and well-marketed, can be huge revenue and profit drivers for the company.
By failing to mention price, and the very strong financial motivation for a company to be first-to-market with a novel drug in this category, the reporter misses an opportunity to help educate readers about a source of rising healthcare costs–and to invite a skeptical view of news about unpublished Phase II results about this drug.
Which is why we think this story should not have been published in a newspaper.
The report is silent on the drug’s possible costs.
Our general view on HealthNewsReview.org is that if it’s not too early to project benefits, it’s not too early to discuss costs.
This is especially appropriate given the high costs of current drug treatments for osteoporosis and the recent patent expiration of Merck’s blockbuster drug in this category.
The story reports details about the findings, but fails to put them in context.
How do results compare to existing drugs in terms of bone mass density improvements? This study does not appear to take into account the endpoint of fracture risk. If that’s so, the report should have said so.
The story properly summarizes the side effects: Over one-third of the women in both placebo and treatment groups had nausea, headache, muscle spasms and rash, about 8 percent serious enough to lead them to stop taking the drug.
The story is built around unpublished results of a phase II trial conducted by the company.
The story should have explictly said the results have not been peer-reviewed or published, and that Phase III trials often show different results.
The story does not falsely dramatize or expand the definition of osteoporosis.
The story cites only Merck’s data and researcher. No independent sources are consulted.
The story fails to mention the range of drugs and treatment approaches to osteoporosis, and how their results compare to those seen in this Phase II trial.
The story indicates the osteoporosis drug odanacatib is still in trials and not yet on the market. It explains that a larger Phase III trial is being conducted, and it does not forecast an availability date.
The story explains that the drug under development works by a mechanism that’s different from the current osteoporosis meds.
The story does not draw directly from the Merck press release that announces the results.