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Drug trial success a boost for Arena

Rating

2 Star

Drug trial success a boost for Arena

Our Review Summary

This was a story about a possible new medication in the pipeline that may enable people to lose weight.  It did not include the information needed to understand the relative strength of the study reported about and did not quantify in absolute terms (number of pounds lost)  the benefit that might be attained with the use of this medication.

It was an interesting piece in that it made an attempt to contrast this medication with one that was withdrawn from the market.  However, in light of this comparison, the story should have explained something about the time frame of the current study, and how that compared with the period of time that was needed for the problems with the drug that was withdrawn from the market to be observed.  It should have also mentioned that the current trials with the new medication specifically exclude people with type of heart issue that was seen to be problematic with the withdrawn drug.  The bottom line is that while the company may be optimistic that this drug will not result in harms, there are not yet sufficient data available to determine whether this is the case.  It would have been useful to readers had the story made this clear.

Finally, this was a San Diego paper reporting on “mid-stage” trial results on a San Diego company’s product.  It is doubtful that the paper would report on such results from another company in another location.  Applying that “business news” approach to health care product news is often problematic.  It gives local readers a skewed picture of the research landscape and may give undue weight to the local idea.  

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

If it’s not too early to project that the drug may be submitted to the FDA for approval within a year, then it’s not too early to get some estimate of cost or at least to give some context about the cost of other obesity drugs on the market. 

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

Not Satisfactory

The story detailed that individuals taking lorcaserin lost more weight in 12 weeks than did the individuals who were taking the placebo.  However the story did not provide any information about the magnitude of the difference between the groups, nor did it actually provide absolute quantitative information about the actual amount of weight lost.  The phrase "significantly more weight loss, at least 5 percent of their weight" doesn’t tell readers how much. 

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

Not Satisfactory

Although mentioning the heart valve problems which were seen to occur with the use of a different weight loss medication, there was no mention in this story of the side effects (headache, nausea, and dizziness) which were seen to occur with this medication during the relatively short period of time it was used.  The story also failed to mention whether weight re-gain was common after use of the medication was stopped. Harm is of particular concern with obesity drugs, particularly given the experiences with Fen-Phen which had a similar mechanism of action.

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

Not Satisfactory

Rather than reporting that "People taking the Arena pill experienced significantly more weight loss, at least 5 percent of their weight over 12 weeks, than people taking a placebo"  the story should have provided information about the nature of the study (randomized, placebo controlled trial), the number of people involved in the study (10, 100 or more than 400?) an estimate for the number of pounds being lost and whether or not all people taking the drug lost weight.

Does the story commit disease-mongering?

Satisfactory

Although most of the story did not engage in disease mongering,  the statement by the study’s lead author indicating that the results would ‘provide reason for optimism for the millions of Americans struggling with the obesity epidemic’ could be argued to fall into this category.  It is both hyperbole to conclude that the results of one study provides optimism for millions as well as disease mongering to describe people who are obese as struggling with the obesity epidemic. That statement should have been challenged. 

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

Not Satisfactory

There were no sources of information quoted that were independent of the study or the company developing the drug.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story did not provide any information about other treatment options (currently available medications, lifestyle changes, and surgical interventions) that provide similar or superior weight loss results.

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

Satisfactory

The story was clear that it was reporting on the results of a recent clinical trial and that a request for FDA approval had not yet been made, from which the reader could conclude that the drug is currently not available.

Does the story establish the true novelty of the approach?

Satisfactory

The story described that lorcasein targeted the 5HT-2c serotonin receptor but was specific to the brain receptor as opposed to fenfluramin which was less selective and was found to also target a serotonin receptor in the heart.

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

Not Applicable

We can’t be sure if the story relied solely or largely on a news release.  This was a San Diego paper reporting on a San Diego company’s product in "mid-stage" trials.  It’s doubtful the paper would report on similar results from a company located somewhere else. 

Total Score: 3 of 9 Satisfactory

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