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New Pill Found to Cut Weight With Few Side Effects: Study

Rating

4 Star

New Pill Found to Cut Weight With Few Side Effects: Study

Our Review Summary

The story does a good job placing this drug into the context of the current competition to bring a new blockbuster weight-loss pill to market, and it brings in a critical, independent voice, albeit late in the story. But it doesn’t provide enough details to allow readers to make their own judgments about the quality of the evidence.

 

Why This Matters

The story focuses too much on the drugs and not enough on whether this drug (or any drug) is a viable remedy for obesity.

The story – and the issue – is a big deal because obesity is such a big deal in the US, with major impacts on morbidity, mortality, quality of life, and costs. People, doctors, health plans, and drug companies all want treatment options that help people lose weight and keep it off safely. This story reports on several new drugs that are likely to gain market approval by the FDA, which would effectively double the number of drug treatment options currentlly available to patients and providers. The biggest problem with weight loss drugs in the past has been that the side effects seemed to greatly overshadow their impact on body weight, and all weight loss drugs deserve close scrutiny on their side effect profile. Given the high prevalence of obesity in our country (1/3 of all adults), close attention should be paid to the cost of any new interventions, which if applied broadly could dramatically impact national health care expenditures.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There is a passing reference to costs, which is more than the other two stories provided. But it would not have taken much effort to gather some basic cost ranges for a drug that has to be taken twice a day for at least a year to see results.

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

Satisfactory

The story did give weight loss amounts for people in the study.  We wish they had calculated the number needed to treat – how many people would have to take the drug for how long in order to have one benefit.  The one truly independent voice in this story, Dr. David L. Katz, says "What’s most impressive about this two-year clinical trial is how unimpressive it is." Instead of going on to attribute all of the analysis of what that is to Katz, the story could have gone the extra step of seeing if others shared that view and really bearing down on the numbers to see how strong the results really are. By our rough count, by the second year, they were dealing with a trial consisting of fewer than 500 people.

Nonetheless, because the story met the minimum standard for this criterion, we’ll judge it to be satisfactory.

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

Satisfactory

Mixed bag – but we’ll give this a barely satisfactory score. This story is the only one of the three that we reviewed on this study that buries the fen-phen connection. And none of them take the time to spell out how much damage fen-phen really caused. As with the other stories, it breezes past any side effects or other long-term problems by saying, "(the) team noted that for those taking lorcaserin, there was no increase in heart valve problems as had been seen with the discredited diet drug Fen-Phen. However, common side effects included headache, dizziness and nausea." Although, unlike the other stories, it points out about a competing drug, "FDA briefing documents posted online Tuesday acknowledged Qnexa’s effectiveness in helping patients lose weight, but said the review panel should take into account a number of potential nervous system and psychiatric side effects, the Associated Press reported."

But, again, connected with our "Evidence" criterion comments above, was the study rigorous enough to answer tough questions about safety? We wish the story had explored this more deeply. Can we be sure this drug is safe, since so many prior weight loss drugs fell down on this point?

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

Satisfactory

There’s a troubling sentence in this story that doesn’t appear in the other coverage, "The report is published in the July 15 issue of the New England Journal of Medicine, and was sponsored by Arena Pharmaceuticals, of San Diego, Calif., which used its own doctors as part of the study group." If that’s true, that is something that should have been explored, at least in a sentence or two. Doctors studying themselves seems to defy the whole concept of a double-blind, placebo-controlled, purely scientific study. At the same time, this story does a better job than the other two of making sense of the research for three reasons.

  1. It makes it clear early and repeatedly that this is research sponsored by the company trying to bring this drug to market.
  2. It brings in critical outside voices to help evaluate the findings.
  3. Unlike the other two stories, it highlights that not only did half the people in the study drop out in the first year, half of the remaining participants dropped out in the second year.

Despite our feelings that the limitations of the study could have been emphasized even more, we’ll judge this one satisfactory – especially in light of the competition.

Does the story commit disease-mongering?

Satisfactory

The second sentence begins, "A potential player in fighting the obesity epidemic." That is the sole reference to the problem of obesity, and, although it contributes to the framing of obesity as a disease that needs medication versus a risk factor for disease that can be altered with lifestyle changes, it doesn’t quite register as disease mongering. So we judge this  to be satisfactory.

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

Satisfactory

Of the three, this story makes the best use of outside sources and does the best job of identifying conflicts of interest. It should have taken the extra step of noting Arne Astrup’s conflicts of interest, given that he is the chief "independent" booster of the drug. But in the first two paragraphs it says "industry-funded research," "work was sponsored by the drug manufacturer" and "was sponsored by Arena Pharmaceuticals."

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Like the other two pieces, it ignores the idea that drugs might not work better than exercise or diet. It took one year on a drug for people to lose 13 pounds on average. That’s a little more than 1 pound a month, and that number dropped considerably the second year. As Katz points out, "Among those who remained, lorcaserin produced relatively modest weight loss when combined with diet and exercise counseling, and that weight loss was maintained in over half of the participants only so long as they kept taking the drug…This close look at lorcaserin reaffirms that better daily use of feet and forks holds far greater promise for meaningful, sustainable and affordable weight control than pharmacotherapy." That is something that merited more than just a comment from Katz.

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

Satisfactory

The story makes it clear that this is a drug company study of a drug that is "being considered for approval" by the FDA." It gives a bit of a timeline but could have said how long it might take before the drug, if approved, hits shelves.

Does the story establish the true novelty of the approach?

Satisfactory

The story shows how this drug builds on the successes and failures of fen-phen, although it takes a while to do so. It also explains what the other in-trial drugs do better than was done in the other two stories we reviewed on this study – by WebMD and AP.

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

Satisfactory

We rule this satisfactory because it’s clear that the story goes beyond the news release.

But the top of the story does feature some marketing-like language, including these two quotes: "In this long-term study of lorcaserin for treating patients for obesity, there was good weight loss, outstanding safety profile and the drug was extremely well-tolerated," said lead researcher Dr. Steven Smith… "As patients are looking for additional options and physicians are looking for new tools, [lorcaserin] provides us with a look into the future for what’s going to be available for helping patients lose weight," he added.

Total Score: 8 of 10 Satisfactory

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