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WSJ story on eczema drug trials bereft of study design details

Rating

3 Star

New Eczema Treatments Could Be Available Soon

Our Review Summary

eczemaThis story is an overview about a couple of drugs that treat eczema by preventing the immune system from overreacting. So far, the drugs are faring well in clinical trials, and the companies behind them plan to seek FDA approval later this year.

This story is clear that availability of the drugs must await that approval, but the headline—New Eczema Treatments Could Be Available Soon—ignores the uncertainty surrounding FDA drug approvals. (We saw a similar level of excessive optimism in our review of a news release on a different drug: PR release on mid-stage eczema drug trial suggests benefit but doesn’t quantify.)

The new drugs may, as sources attest, be “safer and potentially more effective” than existing medications. But the story gives short shrift to explaining the clinical evidence underlying those conclusions and offers no information about potential conflicts of interest among the sources.

 

Why This Matters

Atopic dermatitis, or eczema, afflicts millions of individuals and is so severe in an estimated 1.6 million that it limits social life and leads to bouts of depression and suicidal thoughts. Steroid creams help but bring with them long-term side effects. Newer immune modulator drugs may minimize side effects while providing substantial relief.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The costs of these two new medications is not addressed.  Given their possible availability by 2017, the dearth of cost information is a real disservice. Many currently available treatments are very inexpensive, so it is important to know the costs of the newer medications in order to assess if they are a viable alternative for people and for health systems.

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

Satisfactory

The story provides some quantitative comparisons between folks in a treatment group relative to those in a control group: “In late-stage studies, roughly half of patients taking crisaborole had their diseases cleared or nearly cleared, a statistically significant improvement compared with 30% to 41% of patients using moisturizing placebos. The most common side effect was pain where the ointment was applied, experienced by about 4.4% of crisaborole patients and 1.2% of control-group patients.”

This is sufficient for a Satisfactory rating. However, it doesn’t say how long the follow-up period was or if the disease clearing lasted, which are very important pieces of information.

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

Satisfactory

There is a small bit of information on harms at the bottom of the story for one of the two drugs: pain at the site where the ointment is applied in a small number of individuals. This squeaks by with a Satisfactory rating.

But, a reader will be hard pressed to find any information about the possible long-term harms of the injectable drug of interest here–this is concerning because these types of drugs are known to have serious side effects like increased infection or even cancer risk, as this Nature Review article notes. We’re not looking for an exhaustive list, but some acknowledgment that possible long-term harms are plausible and haven’t been studied would have been helpful.

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

Not Satisfactory

Although it becomes apparent midway through the story that someone conducted a study utilizing a control group, this story is strikingly bereft of information about how these clinical trials were carried out.  Readers need access to the evidence, with information about study size, population demographics, drop-out rates, etc.

We also wanted to see more explanation of what the FDA  “breakthrough” designation means, as it’s an often misused term, as we recently pointed out in the blog post “CBS proclaims ‘cancer breakthrough’ – doesn’t explain what FDA means by that term.”

Does the story commit disease-mongering?

Satisfactory

Atopic dermatitis, although not lethal, afflicts millions of Americans and carries with it a high social cost.

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

Not Satisfactory

This story makes it clear that several companies are working to develop medicines that can act as immune modulators, and at least one of the doctors appears to be independent of the research.

It does not, however, make an effort to link its sources to any of those companies. In at least one case, a dermatology professor on the front lines of eczema treatment research offers information in her employer bio indicating that she is a consultant for one of the companies featured in this story.

Does the story compare the new approach with existing alternatives?

Satisfactory

Steroid treatments are mentioned and their numerous side effects emphasized.

It would have been helpful for the story to emphasize the role of non-medical treatment ( water avoidance, moisturizer, etc) since these are mainstays for many people.

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

Satisfactory

The story states that the drug companies involved plan to ask FDA for approval later this year. This is a clear enough signal that the drugs aren’t available yet.

However, by speculating on how these drugs will be used by doctors, some of the statements imply that the drugs will definitely be approved, e.g.: “Many doctors say they expect the drug to benefit patients whose diseases go undertreated because their fears about steroids cause them to use the drugs less frequently than prescribed.”

Many FDA applications for approval can be derailed by unforeseen safety concerns or other issues, and so the passage above could have been toned down to indicate this still all hinges on events that haven’t happened yet.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story notes that, if approved, “crisaborole would be the first new nonsteroidal treatment for eczema in more than a decade.”  But at least two immune modulators have been available to treat eczema for some 15 years (in 2001 the FDA approved tacrolimus and a related drug, pimecrolimus, for such use).  The story does not acknowledge these existing drugs and makes no effort to compare the patient outcomes of the drugs-in-waiting with those of the already available immune modulators.

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

Satisfactory

An existing release from Regeneron takes a deep dive into the Phase 3 trials; the story does not.

Total Score: 6 of 10 Satisfactory

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