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Read Original Story

FDA approves first inhalable version of insulin

Rating

4 Star

FDA approves first inhalable version of insulin

Our Review Summary

This is a story about FDA approval for an inhaled form of insulin marketed as Exubera. The story discusses how this new form of insulin delivery may affect diabetics, possibly increasing adherence to blood sugar management by reducing the need for injected insulin. A cost comparison of the two forms of insulin is provided. There are appropriate caveats from medical professionals who specialize in diabetes care regarding the need for continued insulin injections for some diabetics. These warnings are contradictory to the story’s sub-headline which states that Exubera is an “alternative to daily injections”. (We realize that reporters don’t write headlines, but someone at AP is responsible for it.) Some diabetics, especially those with Type 1 diabetes, may need a longer-acting injected insulin and cannot rely solely on inhaled insulin. The story discusses some potentially serious side effects, such as a decrease in lung capacity in some people, however, there is no data on the incidence of this or other side effects. Overall, there is little quantitative information on the efficacy of the new form of insulin compared with the existing method of insulin delivery. While investors may be interested that this could be a “$1 billion a year seller for Pfizer”, diabetics who are considering inhaled insulin would appreciate quantitative information on the risks and benefits of Exubera.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

Gives a cost comparison with injected insulin. Given that the article stresses the need for injected

insulin as an adjunct to inhaled insulin (in some cases), the cost would be higher.

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

Not Satisfactory

No quantitative data presented. No information on the efficacy

of Exubera at controlling blood sugar as compared to existing methods of insulin delivery. No data on the side effects, or

how many people who did not have pre-pre-existing lung disease experienced inflammation due to Exubera.

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

Not Satisfactory

No quantitative data

presented. No long-term data on the side effects, or how many people who did not have pre-existing lung disease experienced

inflammation due to Exubera.

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

Not Satisfactory

No data from any Exubera trials. No

mention of study design or incidence of side effects.

Does the story commit disease-mongering?

Satisfactory

Provides American Diabetes

Association statistics on prevalence. Does not appear to be disease mongering. Mentions that not all diabetics take insulin

and some people with Type 2 can manage with oral hypoglycemics, diet and exercise. There is some discussion that more

diabetics will take insulin if it is inhaled form, which may or may not be true.

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

Satisfactory

Balanced. FDA, American Diabetes

Association, Juvenile Diabetes Foundation and diabetic patient perspective provided. No conflict of interest noted. (No

mention if anyone received research funding from Pfizer.)

Does the story compare the new approach with existing alternatives?

Satisfactory

Mention of alternative

treatment (i.e. injections alone) and possible treatment needed in conjunction with inhalable insulin. There is mention of

some of the side effects on the lungs (coughing or decrease in lung capacity) , and that the inhaled form of insulin is not

appropriate for all diabetics, especially those with asthma or poorly controlled lung disease. There is a reminder that

diabetics still need to check their blood sugar levels via needles, pens or pumps.

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

Satisfactory

Mentions availability of treatment and that Exubera won’t replace injected insulin.

Does the story establish the true novelty of the approach?

Satisfactory

The story focuses on recent

FDA approval.

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

Not Applicable

No clear evidence that the story relied heavily on a press

release; however, the financial information seems to be PR-driven. While investors may be interested that this could be a

“$1 billion a year seller for Pfizer”, people with diabetes who take daily insulin in this new form would appreciate

quantitative information on the risks and benefits of Exubera.

Total Score: 6 of 9 Satisfactory

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