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TIME is upfront about new psoriasis drug’s black box warning for suicidal behavior risk


4 Star


How a New Psoriasis Drug Is Different From Others

Our Review Summary

psoriasis drug's black box warning

This Time magazine story reports on the FDA approval of a new drug–Siliq–for the treatment of psoriasis, an autoimmune skin disorder.

The story does a good job of outlining the risks of the new drug, citing its link to suicide among users, as well as a number of side effects. The story emphasizes that the risk is great enough to require warning labeling on the packaging.  But, ideally, it would have delved more deeply into the evidence behind this drug, looking at the drug development process and if there are any reasons to be skeptical (as we note in our review of the FDA’s news release on the approval of Siliq, there indeed are).

One quibble about the headline: It stresses that Siliq is “different” than other psoriasis drugs. The story explains this is because it binds with targeted proteins in a slightly different way than other similar drugs. But so far, it’s not known if this matters to anyone.


Why This Matters

Given the suicide risk linked to this drug, it remains unclear how this new treatment will compare in terms of effectiveness and safety to existing medicines when used for longer periods of time in the general population.


Does the story adequately discuss the costs of the intervention?


We’ll give this story credit for mentioning cost, when it states “pricing information is not available at this time.” However, the story would have been stronger if it had explained the known costs of similar injectable drugs, as we mention in our review of the FDA news release on this drug, and as discussed here. It’s likely this new drug would be in a similar price range.

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


This also is a barely passing satisfactory. The story states that, “In the three clinical trials considered for drug approval, more than 50 percent of patients who used Siliq achieved total skin clearance—the ultimate goal of psoriasis treatments—within a year.”  It would have been more helpful to provide more data, but this statement at least gives us a sense of the scale of the benefit.

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


This is a strong point for the story. In the second paragraph, it states that the drug will be sold with a “black box warning” because of “an association with suicidal thoughts and behaviors” among those who took it. It goes further, later on, by saying, “The most common side effects of the drug were joint and muscle pain, headache, fatigue, diarrhea, throat pain, nausea, flu, low white blood cell count, fungal infections and reactions at the injection site.”

As well, the story spends at least two additional paragraphs discussing the link between use of the drug and suicide, and finally, it cites its effect on the immune system and how it should not be taken by people with some chronic conditions, such as Crohn’s disease.

(For more on the checkered history of this drug’s side effects as noted in clinical trials, see this same criterion in our news release review for the FDA approval of Siliq.)

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

Not Satisfactory

In referencing the suicidal risks of use of the drug, the story mentions six clinical trials with 6,200 participants. However, it gives no information about any of the trials themselves or the methodology used in them–information that readers need to be able to evaluate this news.

Does the story commit disease-mongering?


The story does not appear to commit disease-mongering. However, it would have been more helpful it had stated what percentage of patients with psoriasis may have such severe disease, and how “severe” is defined.

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

Not Satisfactory

The story does quote two sources, one an FDA official and the other a member of the medical board of the American Psoriasis Foundation. The story also points out that the APF official “says he has no involvement with the drug or the drug company.” However, the foundation lists Valeant, Siliq’s manufacturer, as a corporate partner, and we think those sorts of details are important to disclose.

Does the story compare the new approach with existing alternatives?


The story discusses other drugs–two of which target a specific protein rather that Siliq’s target of a protein’s receptor molecule–as well as mentioning that the disease can be treated with “topical treatments (like corticosteroids)” and “phototherapy (using an ultraviolet light box or a laser).”

Yet, we wish the story would have explored more deeply the reality that there are a lot of new and expensive drugs available for patients with psoriasis, and where this new drug fits in remains to be seen–especially considering its black box warning.

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


The story deals with the availability issue by saying it “expects to begin sales and marketing in the second half of 2017.”

Does the story establish the true novelty of the approach?


This is a tough call, but we’re leaning toward satisfactory.

The story mentions that the drug targets a specific receptor on the interleukin-17 protein and that this is distinct from other available treatments that also target this protein in a different way.

However, whether these differences result in outcomes that are distinct in terms of benefit/risks isn’t at all clear from the article, but we suspect that’s because they aren’t yet known. There are many examples of drugs that target different aspects of the same cell, protein, etc. that behave in ways that aren’t all that different.

So while this represents a novel target, whether it results in a safer, more effective treatment remains to be seen.

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


The story included comments from an independent source.

Total Score: 8 of 10 Satisfactory


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