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New Inhaled Insulin Shows Promise for Diabetes

Rating

2 Star

New Inhaled Insulin Shows Promise for Diabetes

Our Review Summary

The story reads like an advertisement for the therapeutic superiority of a new treatment for diabetes — a treatment that has not been approved by the FDA, a treatment about which the FDA has requested more data before it can decide whether it’s worth approving.  Neither the article’s author nor anyone interviewed described the details of any clinical trial data that might back up the dramatic claims of superiority. 

 

Why This Matters

Almost no substantiation is provided for many of the far-reaching claims in the story. There are no references to published, presented, or any other type of results besides those from an animal study. The only source we know for sure that was used for the key evidence discussed in the story was an interview with a vice president of the company seeking approval for this product. All studies are not created equal, and the story is begging for context about the studies whence these benefits and risk have come.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Costs are not mentioned. It’s relevant because one of the problems Exubera faced was that it cost about twice as much per day as standard insulin, according to a NY Times article. The overall economic burden of Exubera was influenced by (see page 105 of this journal article) its enormous development costs and the needs for much higher doses than standard insulin, thorough training for patients prior to using the inhaler, and multiple lung function tests.

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

Not Satisfactory

All the claims are qualitative. No quantities are provided to substantiate any of the benefits claimed in the article. With the exception of one animal study and ongoing trials in people with asthma, we aren’t even told the sources of evidence where any of these benefits were presumably demonstrated. A reader is left with the distasteful conclusion that these benefits are real simply because a vice president at the company says so.

The early claim that Afrezza offers superior glucose control over injectable insulin is entirely unsubstantiated. This whole array of products is designed to control blood glucose. The story should not have glossed over the central potential benefit.

The story ends by telling us that the drug company hopes the technology may be used to treat pain and osteoporosis. Of course they hope that. They’d be thrilled if it could cure the common cold, too. Perhaps this sentence was a way of describing ongoing or planned trials in these therapeutic areas, but it’s entirely inappropriate to discuss the hopes of the product’s manufacturer in this context.

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

Not Satisfactory

All the claims are qualitative. That alone would earn an unsatisfactory rating, but the article goes further. Harms are not only presented without quantities, they are described in a vague, unclear, and overly optimistic way. We’re told, in general, that the safety studies "came out clean." That’s overly simplistic without any further detail; even placebos are associated with harms in studies. Then there are the specific issues.

First, consider the potential cancer risks. The only data described are, it seems, from short-term animal studies. The cancer risks that hung over Exubera were not revealed until after it was yanked from the market, and ultimately the association to Exubera wasn’t definitive. To say that Afrezza holds an advantage over Exubera for these reasons based on short-term animal data is unsubstantiated.

Second, pulmonary function. The pulmonary function problems for Exubera are detailed as one of its major flaws, with the implication that they contributed to its ultimate failure. In the second-to-last paragraph, the VP acknowledges that Afrezza "may have" pulmonary harms; however, "once people stopped taking Afrezza, this effect went away." In several studies of Exubera, lung function declines were also reversible after people stopped taking it. Without providing any evidence, the article’s general coloring of Afrezza safety being superior to that of Exubera is speculative and wholly inappropriate.

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

Not Satisfactory

The article makes almost no attempt to evaluate the quality of evidence. In fact, there is a dearth of actual evidence; many claims are presented without sources. When did Afrezza demonstrate that it keeps blood sugar levels closer to normal? How do we know it has "fewer potential risks" than did Exubera? What was the study? What phase were the trials? How many subjects? Has the study been published or presented to the medical community? What was actually newsworthy here to prompt this article to be written at this time? 

(It seems, from other sources available, that the data supporting Afrezza are from Phase III studies, which makes sense given that FDA is considering the drug for approval. But you wouldn’t know that from the article.)

One result in the article was from animals. The quality of that preliminary evidence was not mentioned. The only independent source in the study, Sanjoy Dutta, noted that long-term safety of Afrezza isn’t known; the way the story flows, that comment feels like it refers to the animal data. We assume for the product to be considered by the FDA, his comment probably refers to the status of human trials. The article should not be vague about our knowledge of the drug’s safety, and the glib comparisons to Exubera’s safety are on faith. 

The evidence in this story seems to have one of two sources: a vice president from the company developing the product, or a to-be-given presentation at the American Chemical Society meeting. The article suggests that it was written in advance of the presentation. Perhaps it was based on an early look at the abstract or presentation. If so, several important points should have been made about this type of evidence:
1) Conference presentations are not peer-reviewed. 
2) Evidence presented at a conference is considered preliminary.

Why are there no publications, medical conference presentations, or even human diabetes trials mentioned in the article? All one can conclude from the sources provided is that the therapeutic evidence come from a chemist’s conference or the VP of the company.

Does the story commit disease-mongering?

Satisfactory

 The article does not engage in disease-mongering.

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

Not Satisfactory

One independent source was quoted, who pointed out that safety studies "came out clean" and that we don’t have long-term safety data. He also confirmed the formulation’s mechanism of action and associated hypoglycemia profile. Dr. Leone-Bay’s affiliation with MannKind is identified, as is Dr. Dutta’s role at the Juvenile Diabetes Research Foundation. (The article should have indicated, however, whether Dr. Dutta has any financial relationships with the company that is trying to bring this product to market.)

Nevertheless, the lack of evidence sources, balance, evaluation, and any independent analysis save for one quote precludes a Satisfactory rating on this criterion. Much more of the claims, many explicitly from the VP’s mouth, needed the counterweight of independent eyes. 

Reporters have to be more cautious when using the senior executives of pharma companies for the main source of information on a new product.  These stories in particular should try to find objective, senior scientists in the field who do not work for the company to give an assessment of the new therapy.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does compare Afrezza to available injectable insulin. However, there are a number of different short-acting injectable insulins available, and it’s not clear what is being compared here. The claim of its superiority — it "keeps blood sugar levels at a closer to normal level…than currently available injectible insulin" — is entirely unsubstantiated. We can’t rate it Satisfactory for making this critical comparison in an unclear, unsupported fashion.

While it also compares Afrezza to Exubera, Exubera is no longer an available alternative. The main issue here is that Afrezza needs to be compared to short-acting, injectable insulin designed for preprandial use, not a medication that has been discontinued.

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

Satisfactory

The article makes it clear that the product is not approved by the FDA for use at this time. 

It needs to be pointed out that the story makes FDA approval seem like a foregone conclusion. The article is written that way. "It will only replace meal-time insulin," the author writes. No, it would replace meal-time insulin if it’s approved.

Also, the statement that this therapy would replace meal time insulin is not supported by the evidence.  The interviewee would lead the reader to believe that meal-time insulin is dangerous, and the evidence would not support this conclusion.

Does the story establish the true novelty of the approach?

Not Satisfactory

The article doesn’t explain how the inhaler technology differs from that used in Exubera, only that Afrezza is a dry powder dissolved in the lungs, absorbed into the bloodstream.

Also, from what we can see, the overall therapeutic role of Afrezza is no different than that of Exubera. People who need to take insulin to treat their diabetes would need injections of long-acting (basal) insulin and then puffs of mealtime (prandial) insulin. From what we are told in this story, the true novelty of Afrezza over Exubera would be a) its shorter mechanism of action and b) the fact that Exubera has ceased to be. They haven’t demonstrated that Afrezza has a different safety profile in humans from that of Exubera. (Other sources we found quote Dr. Leone-Bay noting that the Afrezza inhaler has unique properties.) The claim of superior glucose control over injectable insulin is unsubstantiated in the story, yet it’s critical information.

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

Satisfactory

The article does not appear to rely on any press release we can find.

Total Score: 3 of 10 Satisfactory

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