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Sanofi Obesity Drug Helps Sugar Levels Of Diabetics in Study

Rating

2 Star

Sanofi Obesity Drug Helps Sugar Levels Of Diabetics in Study

Our Review Summary

This story is about a drug which is currently unavailable in the US that may be useful in the arsenal of treatments for diabetes.  The story was crafted around the results of one single study recently presented at a meeting.  See our primer on "News From Scientific Meetings" to learn about the pitfalls in such reporting. The results have not been critically reviewed by experts in the field.   In addition, it is not clear as to whether the beneficial effects on cholesterol and triglyceride levels are directly due to the effects of the drug itself or derive from the loss in weight/reduction in food intake by the people in the study.

The story mentioned that rimonabant is the first in a new class of drugs that might have use in treating diabetes, but it did not contain much information about its mode of action, how it might be used (alone or in conjunction with other medications and/or lifestyle interventions), or what the nearly 10% discontinuation rate in the trial might suggest.  The FDA has raised major concerns about this drug and rates of depression, and that is not clear from the story.

Although the title of the story makes it sound like use of this drug in the treatment of type II diabetes is a fait accompli, rather than report on the results from a single story, the article would have better served the reader by presenting the back story – which phases of clinical trials have been completed, what are the concerns associated with the drug's use, and where does it fit in the scheme of diabetes treatment.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story didn't discuss the cost of the drug.

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

Not Satisfactory

Although the story informed the reader that half of the people taking the rimonabant brought their blood sugar to the range considered to be the target for good glucose control, the story did not provide information about the starting blood-sugar levels for this cohort.  In addition, the story mentions in passing that the improvements were linked to weight loss.  It is not clear from the story whether weight loss alone was sufficient to elicit the benefits in blood-sugar level observed.

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

Not Satisfactory

The story did an incomplete job on side effects.  It did mention nausea, depressed mood and skin tingling "which led to a discontiuation rate of 9.4%." But the FDA has raised major concerns about this drug and rates of depression, and that is not clear from the story.

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

Not Satisfactory

The evidence presented comes from a study just presented at a scientific meeting.  See our primer on "News From Scientific Meetings" to learn about the pitfalls in such reporting.  Although the results of this study are interesting, it is premature to extrapolate from this to use in treatment.  The story did mention that there are currently a number of clinical trials being conducted that should better inform us about the utility of this particular drug in treating and/or managing diabetes.

This story presents data on rimonibant out of context. There have been other larger studies of rimonibant that have already been reviewed by the FDA. The FDA has already turned down one request for approval of this drug for the US market citing concerns over side effects, especially depression. This study doesn't go into the details of that history in enough detail.

Does the story commit disease-mongering?

Satisfactory

Does not appear to overtly disease monger.

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

Not Satisfactory

Although the story did include the thoughts of two analysts, this story would have been more useful to readers if it had included comments from a clinician or scientist not involved in the study who could have commented on why the benefits of this drug differ from those of others currently used for treating this condition.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

This story reported on the comparison of rimonabant as compared to placebo in a group of individuals with type-two diabetes whose sugar levels were not adequately controlled using diet alone.  Although rimonabant may be the first in a new class of drugs that may someday be used in the treatment of diabetes, the story failed to mention the pharmacologic and lifestyle approaches currently used to treat diabetes.  It did not mention the clear evidence that intensive behavioral counseling for weight loss is effective in improving health outcomes in obese adults, and improving blood sugar control in diabetic patients.

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

Not Satisfactory

The fact that the drug discussed in this story is not currently available in the US is not completely clear in this story.  The article does mention that this drug is available in Europe, but doesn't clearly state it isn't available in the US.  It ends with the prediction that the new data should result in eventual approval of rimonabant by the FDA, though the time frame for such approval is not predictable.

Does the story establish the true novelty of the approach?

Satisfactory

It's clear from the story that this is a relatively new drug in a new class of drugs for obesity/diabetes treatment, and that this research is looking at a possible new use for the drug. 

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

Satisfactory

Because the story turned to several independent sources, it does not appear that it relied solely or largely on a news release.

Total Score: 3 of 10 Satisfactory

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