This story explains that the results are preliminary and gives readers the right basic information about the study, but the study’s findings and its limitations warranted more explanation.
As the story notes, we have been down this road before with diabetes drugs. Avandia was promoted as a breakthrough for people with diabetes until 2010 when it was found to cause heart attacks. Because diabetes affects so many people worldwide, it is especially important to take a hard look at the evidence for any new drug being touted. The story went part of the way but could have asked a few more tough questions in the same amount of space.
This early, drugmaker-funded study only examined outcomes for three months, and additional studies that follow patients over a longer period of time examining harms and benefits will be needed before this drug hits the market.
It’s too early to discuss costs for this specific drug, although some mention of the costs of competing drugs would have been helpful.
The story only gives percentage differences when talking about the hypoglycemia risk. The actual benefit in lowering blood sugar levels is vague. It says, “After 12 weeks, all the patients taking the different doses of TAK-875 had significant drops in their blood sugar levels, the researchers said. A similar reduction occurred in patients taking glimepiride. However, the incidence of episodes of hypoglycemia was much lower among patients taking TAK-875 (2 percent) than among those taking glimepiride (19 percent) and the same as those taking the placebo (2 percent).”
There are numbers attached to the potential harms, but there is so little context that it would be hard for readers to make any sense of the numbers. It says, “The incidence of treatment-related side effects was 49 percent among patients taking TAK-875, 48 percent among those in the placebo group, and 61 percent among those in the glimepiride group, according to the researchers.” What does this mean, exactly? What specific types of side effects were experienced, and were some of them severe?
The story provides a concise explanation of the way the trial was conducted. It mentioned that this was a Phase II clinical trial, but it never explained that this a phase of investigation in which the researchers are trying to figure out the most effective dose of the medication that has the least amount of side effects. It is not designed primarily to show anything about how well the drug works. Yet the story emphasized “shows promise” in the headline. It is essential to convey to readers the preliminary nature of this research news – especially given the track record of past diabetes drug developments – mentioned in the story. A little more information about the limitations of drawing conclusions from Phase II study findings could have been easily and concisely added to the article.
The story does not engage in disease mongering and instead offers a brief and accurate description of the disease. It says, “Type 2 diabetes is the more prevalent form of the disease, accounting for about 90 percent of cases. Often tied to obesity, type 2 diabetes involves a gradual decline in how insulin responds to changes in blood sugar (glucose).”
The story says clearly that the study was funded by the company making the drug being studied: “The study was funded by Takeda Pharmaceutical (which is developing the drug), and appears online Feb. 26 in The Lancet.” The story also includes two valuable comments from independent researchers. Dr. Loren Wissner Green says that, “until more is known about short-term and long-term cardiovascular effects, we need to proceed with moderated enthusiasm for each new drug and drug mechanism.” And Dr. Minisha Sood, says that “further investigation is warranted, especially including [heart disease] patients.”
The story does not directly compare alternatives, but it puts the experimental drug in the right context through comments from Dr. Loren Wissner Greene. “She noted that glitazones — a separate class of newer drugs such as Rezulin, Avandia and Actos that also target insulin resistance — have all shown initial promise in clinical trials before worrisome side effects began to surface in users (Avandia was recently withdrawn from the U.S. market due to heart risks).”
Right in the headline, the story shows that the drug is not widely available, calling it “experimental.” Also, the lead of the story says that the findings are “according to the results of a phase 2 clinical trial.” However, the story did not specifically clarify that this drug has years to go before it ever reaches the market.
The story includes this appropriate caveat in the context of “novelty”:
In a journal commentary, Clifford Bailey of Aston University in Birmingham, England, cautioned that, “on the journey to approval of a new class of treatment for type 2 diabetes, many questions will be asked of [drugs such as TAK-875],” including questions of how long they might remain effective, as well as safety issues.
The story does not rely on this press release from the University of Michigan.