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FDA approves anti-nausea patch for chemo patients

Rating

3 Star

FDA approves anti-nausea patch for chemo patients

Our Review Summary

This AP story about Sancuso, a transdermal patch that delivers anti-nausea medication to cancer patients undergoing chemotherapy, is seriously flawed.

  • The story cites no independent sources. It quotes a consultant for the company, a spokesman for the company, and a participant in the clinical trials who is satisfied with his treatment. 
  • It does not cite the evidence upon which the product was approved, nor does it attempt to quantify the benefits or risks.
  • It predicts imminent availability yet does not report price.

A more diligent reporter might have done a Web search on the company and product name, and discovered that the Scottish maker of the drug, ProStrakan, took the unusual action beginning to manufacture the patch in August, weeks before approval had been granted. It’s hard to tell what this might mean. But it would be worth asking a few questions about this, both of company officials and independent sources.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story says the company has not projected costs for the patch. It’s good that the reporter asked.

But the news release issued by the drug’s maker predicts sales of $100 million each in the U.S. and Europe, so clearly someone at the company has an idea how much each patch will cost.

A more diligent reporter would have pushed for a price based on the information in the release, and compared it to costs of the oral medication against which the patch was tested.

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

Not Satisfactory

The story does not quantify the benefits of treatment.

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

Satisfactory

The report cites the one significant side effect mentioned in the FDA material, constipation. It also mentions that this can lead to a dangerous bowel obstruction.

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

Not Satisfactory

The report does not cite the evidence of efficacy and safety upon which FDA approval is based.

Does the story commit disease-mongering?

Satisfactory

The anecdote with the patient (the same patient profiled in the company’s news release) who reported signficant relief from his nausea with the patch is a bit too neat and an easy appeal to emotion.

But the nausea that often accompanies chemo is very serious in that it can compromise nutrition, and therefore resilience and recovery. In the end, we rule that the use of this single anecdote does not constitute disease-mongering. 

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

Not Satisfactory

The only sources used are a nurse practitioner who is consultant to the drug’s maker, a company spokeswoman and a patient who participated in the clinical trials. No independent sources are used.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story says the patch is another way to administer a common anti-nausea medication usually given by mouth. That treatment is the most common alternative. 

Most other anti-nausea treatments, including ginger and guided imagery, are considered less effective and need not be mentioned here.  

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

Not Satisfactory

The report makes plain that Sancuso, an anti-nausea patch for chemotherapy patients, has just been approved by the FDA and is not yet available.

But the story states that the patch is expected to be available by the end of the year. No source is cited.

This prediction should have been attributed–at least to the news release associated with the FDA approval, whose subhead states, "US Launch Planned Before End of 2008".

Finally, the lede of the story says "cancer patients will soon be able" to use the patch. More conditional phrasing would have been more accurate.

Does the story establish the true novelty of the approach?

Satisfactory

The story makes plain that the patch is a novel way to administer a widely used medication normally taken in oral form.

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

Not Applicable

We have no evidence of text or quotes being lifted directly from a news release.  But the same nurse practitioner and same patient are used in the story as are used in the company’s news release. So we are at least suspicious of how much enterprise reporting went into this story.  Nonethless, since we have no evidence of direct influence, we rule this an uncertain N/A.

Total Score: 4 of 9 Satisfactory

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