This news release focuses on a study of a new drug, tivanisiran, to treat dry eyes that was presented at a recent medical conference. It mentions the completion of both phase I and phase 2 trials and the start of a phase 3 trial, but it neglects to provide any of the details of the research. There is nothing offered about costs, the benefits or the harms of using the drug. It refers to the terms of “dry eye disease” or “dry eyes syndrome” repeatedly even though these are not recognized medical conditions.
When it comes to health and medical news, journalists and other members of the public deserve useful information that can be used to evaluate a new treatment. The research summarized here is in far too early a stage to warrant distributing a news release.
There is no discussion of the potential cost of this new medication, tivanisiran. We do know, however, that current other treatments for dry eyes can be expensive. Cyclosporine A drops, for example, may run as high as $400 a month. There is no indication that tivanisiran might be more affordable to patients, or if insurers might cover the cost of this news drug.
There is no effort made in this release to provide any numbers that would put the benefits of using tivanisiran in context. It does quote a scientist working on the treatment endorsing the drug:
According to Ana Isabel Jiménez, Director of R&D at Sylentis, “we trust in our technology, innovative in this field, and we hope that tivanisiran will soon become a real alternative for the treatment of millions of people that suffer dry eye disease around the world.”
Likewise, there is no mention of potential harms that use of tivanisiran might cause to patients. Since one of the earlier studies was a safety trial it would have been appropriate to include those results in the release.
There is no evidence included in the release, despite the headline that says the drugmaker “announces the results of tivanisiran for dry eye syndrome.” The release only notes that the drug completed both phase I and phase 2 trials, (for safety and optimum dosage) and that a phase 3 trial is starting.
The release doesn’t point readers to any of the earlier trials. It should be noted that these results were reported at a medical conference and have not been peer-reviewed or published in a medical journal.
This release crosses the line into disease mongering with its repeat references to “dry eye disease” and “dry eye syndrome” which are not recognized medical conditions. Dry eyes can be caused by numerous things, ranging from side effects of medications to normal aging.
PharmaMar, the parent company of he drugmaker, is listed as the study funder on the EurkekAlert! website which hosts the news release. We encourage news releases to include sponsors and conflict of interest information in the body of the news release so that information follows when the release is picked up verbatim by news aggregators.
The release mentions alternatives to tivanisiran:
“Dry eye can be treated with cyclosporin drops or autologous serum, but there is as yet no specific product for chronic treatment of the ocular pain related to dry eye syndrome; oral analgesics or anaesthetics are used in general. However, the main treatment consists of artificial tears, in the form of drops, gel or creams. Preservative-free eye drops have generally been found to offer the best long-term response.”
The American Optometric Association publishes a patient pamphlet that provides additional management options.
A scientist working for the drugmaker says she hopes “that tivanisiran will soon become a real alternative.” Savvy readers will note that the drug is still in development and that the drug is not yet ready for patient use outside of a research setting.
This treatment, at least for dry eye, is novel since it is using a different approach to dealing with dry eyes than currently available medications use. But it’s important to keep in mind that the treatment is still preliminary and must be studied in larger trials before being submitted for FDA approval.
The unjustifiable use of the terms “dry eye disease” and “dry eye syndrome” have already been addressed under the Disease Mongering criteria.
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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