This is a brief story on findings from a phase II trial of a new oral insulin medication conducted by Oramed, a pharmaceutical company.
The story gives us the basics on the study design and findings. It’s made clear that the drug must undergo further testing before it’s approved for use.
The only commentary, though, was from the CEO. Given the nature of the research–unpublished and coming directly from a pharmaceutical company–an outside source would have made this story stronger. (We also reviewed the news release this story seems to be based on.)
The worldwide occurrence of diabetes is about 400 million people, 90 percent of whom have type II diabetes. Many of these people eventually have to supplement their oral medications with injected insulin. Previously, oral delivery of insulin was considered impossible because the drug degrades in the digestive system, but Oramed believes they have overcome this problem.
A comparison of cost to currently available long-acting insulin would have been informative, but the report is on a trial for safety and efficacy, so this is preliminary.
The story reports a decrease in “mean night-time glucose of nearly 6.5 percent” compared with a placebo. However, there is no indication of what that means for control of type II diabetes–absolute numbers are needed to be useful. The difference appears to be small and similar to what already-available oral medications can do. It’s also not clear if these patients continued to take metformin or not.
This story states that there were “no reported serious adverse side effects and no issues with hypoglycemia, or dangerously low blood sugar.”
The story tells us this was a randomly chosen, blinded study of 180 people over 28 days, and considered a Phase II trial. The story also mentions that stage III trials still need to be done, which is when the drug might be considered for approval. These are important details.
But, because it’s an unpublished study, no one outside of the company has taken a look at the evidence. This story should have had a stronger signal that this is potentially straying from the realm of science and into marketing.
Type II diabetes is a known disease of the industrial world and the numbers of people are increasing while the ages at which they are diagnosed is decreasing. An oral insulin would aid people in controlling their blood sugar levels.
The story includes comments from the CEO. Getting an independent voice is especially important when the data is preliminary and comes from the pharmaceutical company.
The story does say that this drug is intended for those for whom metformin, a standard treatment for type II diabetes, is no longer sufficient. But because there are many alternatives for diabetes management, and none were mentioned, this is Not Satisfactory.
The story makes it clear that the drug needs more research before it will be reviewed by the FDA for approval.
The story makes it clear that if this drug delivers the necessary insulin by mouth, then this would be a novel advance in treatment–and a “multibillion-dollar product.”
Because the story contains original quotes not found in the news release, this squeaks by as Satisfactory. It is clear, however, that this story is being published because of promotional outreach by the company, and the lack of outside perspective makes this feel more like a news release than a piece of journalism. (We also reviewed the news release.)
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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