NOTE TO READERS: When this project lost substantial funding at the end of 2018, I lost the ability to continue publishing criteria-driven news story reviews and PR news release reviews - once the bread-and-butter of the site going back to 2006. The 3,200 archived reviews, while still educational, are getting old and difficult for me to technically maintain on the back end of the website. So I am announcing that I plan to remove these reviews from the site by April 1, 2021. The blog and the toolkit - two of the most popular features on the site - will remain. If you wish to peruse the reviews before they disappear, please do so by the end of March 2021. After that date you may still be able to access them via the Internet Archive Wayback Machine - https://archive.org/web/.
Read Original Story

Experimental Drug Shows Promise Against Type 2 Diabetes

Rating

4 Star

Categories

Experimental Drug Shows Promise Against Type 2 Diabetes

Our Review Summary

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.

 

Why This Matters

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.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Applicable

It’s too early to discuss costs for this specific drug, although some mention of the costs of competing drugs would have been helpful.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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).”

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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?

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

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.

Does the story commit disease-mongering?

Satisfactory

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).”

Does the story use independent sources and identify conflicts of interest?

Satisfactory

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.”

Does the story compare the new approach with existing alternatives?

Satisfactory

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).”

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

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.

Does the story establish the true novelty of the approach?

Satisfactory

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.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story does not rely on this press release from the University of Michigan.

Total Score: 6 of 9 Satisfactory

Comments (1)

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.

Aggie

March 15, 2012 at 11:00 pm

The real question with all the type 2 diabetes drugs is do they do anything other than improve surrogate measures? Yes, they make the numbers look better, but do they accomplish anything meaningful in the reduction of the complcations of diabetes over the long haul?

Reply