What we have here is a tentative demonstration of a new concept in allergy treatment, reported in a brief letter to the editor of a medical journal, which is puffed up to look like proof of effectiveness. Meanwhile, looming challenges of both safety and cost are soft-pedaled or ignored. There is legitimate news that an anti-allergy effect of a cancer drug (ibrutinib), previously observed in lab and animal experiments, has now been seen in two patients. But the release buries the limitations of the study and ignores serious safety and cost challenges, while highlighting speculative musings about food allergy treatments that were not part of this study. Most readers of this release would likely be surprised to learn that ibrutinib has potentially life-threatening side effects and that the dosage studied costs more than $100/day.
Proof-of-concept studies have their place, but news releases should not pretend that they demonstrate either effectiveness, safety or practicality. This release misleads readers by focusing on the prevention and treatment of serious food allergies, which this study did not look at, while minimizing research challenges that lie ahead.
Although this line of research is in the earliest stage of human tests, the release should have noted that the drug, as it was used in the study, cost more than $100 a day. Obviously, cost is an issue that would have to be dealt with before declaring that this treatment could be used routinely by allergy sufferers.
The release provides only relative reductions in skin reactivity tests. It reports neither absolute numbers nor a description of the clinical relevance; that is, whether the patients felt their allergies symptoms had improved. The release does not tell readers that one of the patients continued to take anti-allergy medication or that the other patient was not taking any anti-allergy medication; these points in the research report raise questions about whether the patients felt any improvement in their allergy symptoms.
There is also no mention that the researchers wrote in their journal letter that they have yet to show that the drug has benefits for people with more than one allergy. The release touts speculation about the drug’s potential to prevent or treat food allergies, even though such trials are just getting started. The senior author of the letter to the editor noted, however: “I don’t know if this or similar drugs will ever make it possible for a peanut-allergic person to eat peanut butter and jelly sandwiches, but we’re excited to use this approach to teach us how to lessen the risks of food allergy reactions.”
Readers of this release get no alert that the labeling of ibrutinib warns of potentially life-threatening bleeding, infections, decreased blood cell counts, heart rhythm problems and also that patients commonly suffer diarrhea. The release not only fails to mention any of these risks and side effects, it projects an unsupported aura of safety by describing the drug as an FDA-approved “successful and less-toxic alternative to chemotherapy.”
While the release does note that this was a pilot study, the important detail that it included only two patients is buried two-thirds of the way down. The release also overstates the scope of the work by referring to “patients who were allergic to allergens such as cat dander and ragweed,” when in fact there was just one patient who had a skin test reaction to cat dander and just one patient who had a skin test reaction to ragweed.
The release should have been more clear that this study was just an early step toward demonstrating that blocking a protein known as Bruton’s tyrosine kinase (BTK) can have an effect on allergic reactions in humans, but that nothing is known about whether this effect can be repeated usefully, reliably or safely.
We rarely see overt disease mongering in the news releases and stories we review. This is a notable exception. The release notes in the opening paragraph: “The promising data from this pilot study could have greater implications for adults with food allergies,” tantalizing legions of people with allergies to peanuts and other foods. Some news stories jumped on that connection. But the study did not include any people with food allergies, just one patient with a cat dander reaction and one patient with a ragweed reaction.
The study reports that this study was funded by a 2016 Dixon Translational Research Grant. However, it fails to disclose the list of industry connections, patents, stock options and other items the researchers attached to their journal letter. Two of the seven authors have ties to AbbVie, the co-producer of ibrutininib. AbbVie and Northwestern University have also announced a five-year deal to collaborate on cancer research.
The release does not compare this approach to existing allergies treatments. There are numerous over-the-counter and prescription medications available, along with air filters and masks for airborne allergens.
The release is clear that the drug is still being studied. It does not make any claims about when such treatments might be available.
It is appropriate to call this approach new. Indeed, this is the first test in humans of the effect of a BTK blocker on allergic reactions. However, other than the data from just two patients, most of the release refers to speculation that began with laboratory and animal experiments by a variety of researchers in recent years.
As noted above, the release is replete with speculation about possible benefits that have yet to be tested. It likened the drug to “the holy grail of food allergy treatment” even though food allergies weren’t part of the study.
The headline also strikes us as irresponsible and misleading: “New cancer drug can prevent reactions to common airborne allergens.”
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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