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Weight-Loss Drugs Face High Hurdles At FDA

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3 Star

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Weight-Loss Drugs Face High Hurdles At FDA

Our Review Summary

We like how the blog post linked to the FDA briefing documents, allowing interested readers to do more homework if they wished. That’s a little addition – that can be a big help for readers – and for the completeness of the overall reporting effort.

However, the story could have directly included – even at a high level – some of the data from the clinical trials so that readers could have an appreciation for the magnitude of the weight loss seen. The one line – “Qnexa does appear to help many people lose at 5 percent of their body weight” – wasn’t sufficient in our view.

 

Why This Matters

The tradeoffs of potential benefits and harms with this drug represent vital public health and safety issues – and, if approved, set the stage for important physician-patient shared decision-making discussions.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No mention of Qnexa’s cost. As the New York Times reported, “Through a regulatory loophole of sorts, many obesity doctors prescribe two separate drugs that, when taken together, are essentially the same medicine.” So, at least some estimate of the cost of those components could have been given.  Or analysts could have helped project what expected Qnexa costs would be.

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

Not Satisfactory

Here’s the good part.   The story focuses on the regulatory hurdle.  We appreciate the sidebar that includes a link to FDA’s 200-page review documents.  From those documents, the story notes that “many people lose 5% of their body weight” after using the drug. And there was reference to some data on lowering blood pressure.

But here’s where we yearned for more/better info: Instead of riding the patient anecdote, the story could have provided some real data.  The past proceedings of the Advisory Committee are readily available.  The biggest issue with “diet pills” is that if you have not altered your lifestyle, you will gain the weight back again. As noted in our summary above, the story could have directly included – even at a high level – some of the data from the clinical trials so that readers could have an appreciation for the magnitude of the weight loss seen. The one line – “Qnexa does appear to help many people lose at 5 percent of their body weight” – just doesn’t tell the story.

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

Satisfactory

The story sidebar notes – from the FDA briefing documents: “The review noted continued concerns that Qnexa can increase the risk for several possible side effects, including increased heart rate, birth defects and thinking problems such as memory lapses and confusion.”

It also included these caveats:

“There’s been a long history with obesity drugs that we’ve had to take off the market. You recall the fen-phen episode where a significant number of people got heart-valve defects,” says Janet Woodcock, a top FDA official.

Woodcock argues that the agency has to be extra-careful with weight-loss drugs, because chances are it won’t just be obese people taking them.

“When you’re talking about a drug where it could go into literally tens of millions of Americans, there has to be attention to safety,” Woodcock says.

What might look like a rare problem now could turn into another public health disaster, she says.

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

Not Satisfactory

The story could have helped readers grasp the weight of the evidence – by at least linking to the transcripts and the summary of the FDA Advisory Panel in 2010 which are readily available.

Does the story commit disease-mongering?

Satisfactory

There was no disease-mongering of overweight or obesity.

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

Satisfactory

Several independent sources were cited.

Does the story compare the new approach with existing alternatives?

Satisfactory

One source quoted captured some of the dilemma regarding alternatives:  “”We go from Weight Watchers to bariatric surgery. And the fact that there isn’t … medical treatments for obesity, including pharmaceuticals, really is a challenge, considering how big the problem is in this country.”

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

Satisfactory

The whole story was about the FDA review of the drug and its meeting next week.

As noted above, the New York Times reported, “Through a regulatory loophole of sorts, many obesity doctors prescribe two separate drugs that, when taken together, are essentially the same medicine.” This was an interesting perspective that the NPR post didn’t include.

Does the story establish the true novelty of the approach?

Not Satisfactory

As the caption under the story’s photo explains, “The FDA hasn’t approved a new weight-loss drug since 1999.”  But the story didn’t explain, as a Bloomberg story did, that “Qnexa is one of three obesity drugs vying to be the first in 13 years on the market.”  We think that was an important angle to include.

It also could have explained that Qnexa is a combination of two drugs that are well known to cause weight loss (phentermine, the phen in phen-fen and topiramate an antiseizure drug that has weight loss as a side effect).

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

Satisfactory

It’s clear that this story did not rely solely or largely on a news release.

Total Score: 6 of 10 Satisfactory

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