This Reuters story reports on a clinical trial testing the use of a new experimental drug, teprotumumab, to relieve Graves’ ophthalmopathy, the bulging eyes that often affect patients with Graves’ disease.
The story does a lot of things well–it adequately quantifies the benefits from use of the drug as well as outlining the potential risks associated with it. We’re also given some key details about the study design. However, the story doesn’t provide information from independent sources about the drug’s use, nor does it address the issue of the drug’s potential cost.
According to the National Institute of Diabetes and Digestive and Kidney Diseases, Graves’ disease is the most common form of hyperthyroidism in the United States and between 25 and 30 percent of those patients may go on to develop the bulging eye symptom. In 2 to 5 percent, the bulging is severe. A new drug that could address this condition, even in mild cases, would offer a new, and seemingly simpler remedy than those currently available.
There is no mention of the potential price of teprotumumab, an important piece of context for the story. Will patients be able to afford this new therapy if it becomes available? Even if exact numbers numbers can’t be pinned down, we know that there are other treatments used to treat the eye bulging that often comes with Grave’s disease and those cost figures should be available. Some suggestion as to whether the new drug might be cheaper or more expensive than are current approaches would be helpful for readers.
The story clearly states that 43 percent of the patients who were given teprotumumab in this trial experienced a reduction of “at least 2 millimeters in eye protrusion by the sixth week compared to 4 percent in the placebo group.” One of the researchers is quoted as saying, “That’s something that we almost never see in someone who’s manifested the degree of disease one needed to have in order to get into the study.” The story also points out that this level of reduction “is similar to that reported after decompression surgery.”
The story mentions that using the new drug brought on double vision among 50 percent of the patients by six months. Only 10 percent of the patients admitted double vision at the start of the trial. Also, the story states that “High blood sugar was also a key side effect in participants who already had diabetes, the study team notes, but adjusting diabetes medications solved that problem.”
The story provides important details that let the readers know this was a controlled trial, with a placebo group. We’re told how many people were in the study. It also warns that the study involved patients with active disease “of recent onset” and that the study didn’t look at patients whose disease was “milder, less active, or stable.”
No apparent disease mongering here.
The only source quoted in this story was the lead investigator in the trial. No information from other unaffiliated experts was included. The story does mention that River Vision Development Corporation funded the trial, but it doesn’t mention that several investigators reported receiving fees from River Vision Development Corporation separate from the study. It does not mention grant support from the National Institutes of Health, National Eye Institute, Research to Prevent Blindness, the Bell Charitable Foundation, among others.
The story says, “The typical treatment for Graves’ eyes is glucocorticoids, which are not always effective and also have side effects, the study team notes.” It also says the new treatment is comparable to the effect seen with decompression surgery, another option.
The story does state that FDA approval for this use of the drug could come sometime in 2018 so readers can easily assume the drug is not available now and won’t be for the immediate future. It said that the next phase of the clinical trial is expected to begin within a month or two.
There are other treatments for both Graves’ disease and the eye bulging that often accompanies it and these range from medications to surgery. A medication that might provide relief from the condition without invasive efforts is certainly novel enough to warrant a story.
There’s no evidence that the story relied solely on a news release.